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Presentation on EU Regulatory & Quality System.

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This presentation describes the EU Quality & Regulatory System.

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Presentation on EU Regulatory & Quality System.

  1. 1. This presentation is compiled by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 10/17/2015 1
  2. 2. This presentation is compiled from freely available resource like the website of EMA & EU. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 10/17/2015 2 Drug Regulations : Online Resource for Latest Information
  3. 3.  The regulatory system for supervision of pharmaceutical manufacturers and GMP inspection in the European Union is one of the most advanced in the world.  This system is often poorly understood outside the EU nations  This presentation gives an explanation of the EU system. 10/17/2015 3Drug Regulations : Online Resource for Latest Information
  4. 4.  The European Union includes 28 Member States located in Europe, which are: ◦ Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and United Kingdom.  The EU total population is about 500 million people. 10/17/2015 4Drug Regulations : Online Resource for Latest Information
  5. 5.  The European Union operates through a system of ◦ Supranational independent institutions and ◦ Intergovernmental negotiated decisions by its Member States.  It is a legal entity and can negotiate international agreements on behalf of its Member States. 10/17/2015 5Drug Regulations : Online Resource for Latest Information
  6. 6.  Three main EU institutions. ◦ The European Parliament, ◦ The Council of the European Union and ◦ The European Commission  Ordinary Legislative Procedure ◦ Produces Policies and laws that apply throughout the European Union are formulated by this process.  (formerly "co-decision") 10/17/2015 6Drug Regulations : Online Resource for Latest Information
  7. 7.  The European Union has developed a single market ◦ Standardized system of laws that apply in all its Member States.  Authorization of medicines and the supervision of safety of medicines. ◦ Same rules and harmonized procedures apply to all the 28 Member States 10/17/2015 7Drug Regulations : Online Resource for Latest Information
  8. 8.  Regulatory system based on a network of decentralized National Competent Authorities (NCAs) in the Member States,  Supported and coordinated by a centralized agency, the European Medicines Agency. (EMA). ◦ Link to EMA website 10/17/2015 8Drug Regulations : Online Resource for Latest Information
  9. 9.  The EMA was created in 1995 to coordinate the existing scientific resources in the EU Member States  EMA: an interface for cooperation and coordination of Member States’ activities with respect to medicinal products.  EMA scientific decisions are made through its scientific committees. ◦ Members are chosen on the bases of their scientific expertise and are appointed by the Member States.  One of the main roles of EMA is to mobilize scientific resources in the Member States. ◦ Many of its scientific activities are carried out through a large network of scientific experts made available by the Member States. 10/17/2015 9Drug Regulations : Online Resource for Latest Information
  10. 10.  The European Commission’s role is multifaceted and focuses on the following: ◦ Right of initiative: To propose new or amending legislation for the pharmaceutical sector ◦ Implementation: To adopt implementing measures as well as to ensure and monitor the correct application of EU law ◦ Risk management: To grant EU-wide marketing authorizations for centralized products or maximum residue limits on the basis of a scientific opinion of the EMA Supervisory authority: ◦ To oversee the activities of the EMA in compliance with the mandate of the EMA, EU law and the EU policy objectives Global outreach: ◦ To ensure appropriate collaboration with relevant international partners and to promote the EU system globally 10/17/2015 10Drug Regulations : Online Resource for Latest Information
  11. 11.  System for Marketing Authorization (MA) of medicines & the referral procedure,  European Commission, the EMA and the Member States cooperate to a great extent in its implementation  The EU national, decentralized and mutual recognition MA procedures coexist with the centralized procedure ◦ Marketing Authorization Procedure ◦ See table in next slide. 10/17/2015 11Drug Regulations : Online Resource for Latest Information
  12. 12. 10/17/2015 12Drug Regulations : Online Resource for Latest Information
  13. 13.  An EU binding mechanism ◦ Ensures that the same measures are applied to products subject to national, decentralized and mutual recognition MA procedures.  This procedure may be notably invoked when ◦ The conditions of authorizations need to be reviewed in the light of quality, safety and efficacy data (Union Interest Referral), ◦ Member States have adopted different decisions regarding products that are authorized in at least two Member States (Divergent Decision Referral). ◦ In the absence of agreement among Member States in the course of the mutual recognition or decentralized authorization procedures  (Mutual Recognition and Decentralised Referral). 10/17/2015 13Drug Regulations : Online Resource for Latest Information
  14. 14.  This mechanism involves an opinion from the appropriate EMA committee.  Results in a decision of the European Commission that is binding for all Member States  See link for details 10/17/2015 14Drug Regulations : Online Resource for Latest Information
  15. 15.  Fundamental aspect  Legislation applicable to pharmaceuticals in the European Union is the same irrespective of the Member State or authorization route of the product, as it is developed at Union level.  See the link 10/17/2015 15Drug Regulations : Online Resource for Latest Information
  16. 16.  Clinical trials of Investigational Medicinal Products (IMPs) require ◦ Authorization by each NCA and ◦ A favorable opinion by an ethics committee in which the clinical trial takes place and is granted in the form of a Clinical Trial Authorization (CTA) ◦ (http://ec.europa.eu/health/human-use/clinical- trials/index_en.htm).  The assessment for a CTA takes into account the holding of an appropriate authorization for each EU site of manufacture or importation. 10/17/2015 16Drug Regulations : Online Resource for Latest Information
  17. 17.  Any manufacturer, no matter where it is located, must comply with GMP if they are to supply products to the EU.  There is a single system for GMP supervision of manufacturers which is valid throughout all the EU Member States;  This applies to ◦ Authorized medicinal products for human or veterinary use placed on the market and ◦ IMPs used in clinical trials. 10/17/2015 17Drug Regulations : Online Resource for Latest Information
  18. 18.  The system is based on two main pillars, ◦ The authorization/registration of operators in the supply chain and ◦ Inspection of those operators  To ensure compliance with  legal requirements,  GMP  Requirements in the MA or CTA. 10/17/2015 18Drug Regulations : Online Resource for Latest Information
  19. 19.  Manufacturers and importers of medicinal products located in the EU need to be authorized to carry out their activities.  This obligation also applies to manufacturers and importers of products only intended for export and IMPs.  The C A of each Member State are responsible for granting the authorizations  A condition for grant of a manufacturing or import authorization is that the manufacturers must comply with EU GMP. 10/17/2015 19 Drug Regulations : Online Resource for Latest Information
  20. 20.  GMP principles and guidelines are set out in two Directives ◦ One for medicines for human use and ◦ The other for medicines for veterinary use.  More detailed guidelines have been developed through the work of the GMP and GDP Inspectors Working Group  see Link 10/17/2015 20 Drug Regulations : Online Resource for Latest Information
  21. 21.  Manufacturers and importers of medicinal products located in the European Union or manufacturers located in a third country are regularly inspected by an EU competent authority for compliance with EU GMP.  The outcome of these inspections must be accepted by all other EU authorities.  After every inspection a GMP certificate (positive outcome) or noncompliance report (negative outcome) must be issued by the inspecting authority  This is entered in the Eudra GMDP database, which is accessible by regulators in other countries.  Most of this information is also available to the general public.  See Link 10/17/2015 21Drug Regulations : Online Resource for Latest Information
  22. 22.  Inspections of manufacturers are typically requested in order to  Grant or maintain a manufacturing or import authorization (EU sites) or  Assessment, approval and maintenance of an MA (typically sites outside the EU) or CTA. ◦ For example, EMA may request that an EU competent authority undertake a preapproval GMP inspection of a site included in a MA application through the Centralized procedure or ◦ That an EU competent authority undertake periodic repeated post authorization surveillance inspections of sites named in centralized MAs, ◦ In order to verify ongoing compliance with GMP and that the requirements of the MA are being met. 10/17/2015 22 Drug Regulations : Online Resource for Latest Information
  23. 23.  According to EU legislation, the interval for repeated GMP inspection should be based on risk.  As a result, a procedure outlining a risk-based model to frequency of inspections is included in the Compilation of European Union Procedures on Inspections and Exchange of Information  See Link 10/17/2015 23 Drug Regulations : Online Resource for Latest Information
  24. 24.  Manufacturers, importers and distributors of active substance located in the European Union are required to comply with GMP  Must be registered to the National Competent Authority of the Member State where they are located. 10/17/2015 24 Drug Regulations : Online Resource for Latest Information
  25. 25.  For active substances manufactured outside the EU and imported: ◦ Each batch needs to be accompanied by a written confirmation ◦ This should be issued by the competent authority of the country where it is produced ◦ W C should Confirm among other things, that GMP at least equivalent to that in place in the European Union has been applied to its manufacture. ◦ The C Aof the exporting country also needs to confirm that any GMP noncompliance arising at the manufacturing site would be communicated to the European Union.  The receipt of this noncompliance information is via the EMA. 10/17/2015 25Drug Regulations : Online Resource for Latest Information
  26. 26.  The requirement for the written confirmation can only be waived ◦ If the third country is included by the European Commission, after assessment, in a list of countries with an equivalent system of supervision and inspection or, ◦ Exceptionally, in order to ensure availability of medicines in the EU market, if a GMP certificate for the site has been issued by an EU competent authority after inspection. 10/17/2015 26 Drug Regulations : Online Resource for Latest Information
  27. 27.  The requirement for written confirmation, introduced from July 2013 by Directive 2011/62/EU requires that authorities outside of the EU take responsibility for active substances manufactured in their territory, if exported to the EU. ◦ See Link  This requirement caused some debate before its implementation  There were concerns on its potential to cause shortages in the EU, if the exporting authorities were not willing or able to provide the written confirmations,  However this was not the case and countries gave a written confirmation. 10/17/2015 27 Drug Regulations : Online Resource for Latest Information
  28. 28.  The EU legislation places the responsibility for using active substances manufactured in compliance with GMP on ◦ The medicinal product manufacturer or ◦ The importer (in case the medicinal product is manufactured outside the European Union).  The holder of the MA or EU importer must ◦ Verify the registration status of the manufacturer of the active substance and ◦ verify compliance by the manufacturer of active substance with GMP,  This should be done by conducting audits at the manufacturing site.  This compliance can be implemented directly or with use a third party acting under a contract. 10/17/2015 28 Drug Regulations : Online Resource for Latest Information
  29. 29.  Inspections of active substance manufacturers are carried out by EU competent authorities following a risk-based approach, or if there is suspicion of noncompliance.  See Link  Furthermore, every application for an MA must include a confirmation that the holder of the MA has verified compliance of the manufacturer of the active substance with principles and guidelines of GMP.  The confirmation shall contain a reference to the date of the audit  A declaration by the Qualified Person that the outcome of the audit confirms that the manufacturing complies with GMP principles and guidelines.  See Link 10/17/2015 29Drug Regulations : Online Resource for Latest Information
  30. 30.  Inspections of active substance manufacturers may also be organized by the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe, on behalf of the EU.  See Link  The Council of Europe has 47 members including all EU Member States and it has close cooperation with the EU.  EDQM is responsible for developing and maintaining the European Pharmacopoeia. 10/17/2015 30 Drug Regulations : Online Resource for Latest Information
  31. 31.  EDQM issues Certificates of Suitability with the monographs of the European Pharmacopoeia (CEP) that can replace most of the data normally expected in EU MA dossiers for the active substance.  See Link  In order to issue and maintain these certificates, EDQM runs its own inspection program of active substance manufacturers.  Most of the inspections organized by the EDQM are carried out by inspectors from EU inspectorates. 10/17/2015 31 Drug Regulations : Online Resource for Latest Information
  32. 32.  Inspections are carried out by inspectorates of Member States.  In order to avoid duplication it is necessary to identify the Member State responsible for supervision and inspection of any manufacturing sites for the EU market.  This is achieved through the identification of one or more Supervisory Authority (SA);  The SA is the NCA in the EU responsible for the GMP supervision of the site, including granting the manufacturing or import authorization and GMP inspection. 10/17/2015 32 Drug Regulations : Online Resource for Latest Information
  33. 33.  If the manufacturing site is in the EU, the SA is the NCA of the Member State where the site is located.  In cases where the manufacturing site is outside the EU, the SA is the NCA of the Member State in which the importer of the product(s) is located.  Where products from a manufacturing site located in a country outside the EU are imported in more than one Member State, there may be more than one SA, which cooperate in the supervision of the manufacturing site. 10/17/2015 33 Drug Regulations : Online Resource for Latest Information
  34. 34.  An important feature of the supervision system in place in Europe is the role of Qualified Person (QP).  In order to obtain an authorization, EU manufacturers and importers must have at their disposal the services of at least one Qualified Person  The Qualified Person must ◦ Take responsibility for securing that each batch of medicinal product, manufactured or imported, has been manufactured in accordance with EU GMP, and ◦ Must certify compliance with GMP and with the relevant MA(s). ◦ See Link 10/17/2015 34 Drug Regulations : Online Resource for Latest Information
  35. 35.  A batch may only be released by a manufacturer or importer for distribution in the EU after certification by the QP.  Member States are empowered to take administrative and disciplinary measures against QPs if they have failed to fulfil their obligations.  Furthermore, imported batches need to undergo a full retest in the EU to ensure the quality of the product in accordance with the MA specification.  There-testing requirement is waived if there is an operational Mutual Recognition Agreement in place between the EU and the exporting country. 10/17/2015 35Drug Regulations : Online Resource for Latest Information
  36. 36.  The discovery of serious GMP noncompliance may have implications for the Member State, which carries out the inspection, and all Member States.  International authorities would also be involved if the active substance or product be supplied to them.  A mechanism that ensures a coordinated approach for protection of public and/or animal health is taken throughout the European Union .  See Link 10/17/2015 36Drug Regulations : Online Resource for Latest Information
  37. 37.  Objective of this Procedure: ◦ Achieve a coordinated and harmonized assessment ◦ Proportionate supervisory actions ◦ Balance the protection of patients and minimize supply disruptions ◦ Ensure maximum efficiency ◦ Avoid full parallel reviews on a national level across the European Union. 10/17/2015 37 Drug Regulations : Online Resource for Latest Information
  38. 38.  European legislation provides that manufacturer and import authorizations may be suspended or not granted as a result of noncompliance with GMP.  Also, existing MAs for the products affected can be varied, not granted or revoked.  Urgent measures include ◦ Prohibition of manufacture, importation or supply, and/or ◦ Withdrawal of all, or of specific batches from the market. 10/17/2015 38 Drug Regulations : Online Resource for Latest Information
  39. 39.  EUDRA GMDP is a publicly accessible Union database ◦ See Link  A repository of ◦ Manufacturing and import authorizations, ◦ GMP certificates and ◦ Non-compliance reports.  After every GMP inspection carried out by an EU competent authority following information is entered in the database. ◦ A GMP certificate (positive outcome) or ◦ A noncompliance report (negative outcome) 10/17/2015 39 Drug Regulations : Online Resource for Latest Information
  40. 40.  The database includes a planning module (only accessible to the relevant regulators) for coordination of inspections planned by EU authorities in countries outside the European Union.  Data are entered into the planning module in order to facilitate exchange of information between competent authorities and reduce duplication and ensure the best use of inspectional resources.  EMA and EU authorities recognize the global nature of modern pharmaceutical supply chains  They also recognize the need for close collaboration and cooperation with regulatory authorities outside the European Union  Therefore work is ongoing to extend the use of the EudraGMDP database planning module to include exchange of information on inspections planned by authorities outside the European Union. 10/17/2015 40 Drug Regulations : Online Resource for Latest Information
  41. 41.  All the National inspectorates in the Member States should be equivalent as regards the level of supervision they are able to provide.  A number of measures are put in place to ensure that this is the case, summarized in subsequent slides 10/17/2015 41Drug Regulations : Online Resource for Latest Information
  42. 42.  Legislation ◦ The pharmaceutical legislation is developed at EU level. ◦ This is mainly in the form of Regulations and Directives. ◦ Both are applicable to all the Member States. ◦ Regulations are directly applicable to the entire EU territory. ◦ Directives have to be transposed into national legislation, in a timeframe established in the Directive itself, usually 18 months. 10/17/2015 42 Drug Regulations : Online Resource for Latest Information
  43. 43.  Legislation  The EU legal framework for medicinal products is intended to ensure a high level of public health protection and to promote the functioning of the EU internal market.  The system is also designed to encourage innovation.  It is a large body of legislation that ensures extensive harmonization within the European Union, including GMP and inspections.  The pharmaceutical legislation is published in the Official Journal of the European Union. ◦ http://eur- lex.europa.eu/oj/direct-access.html 10/17/2015 43 Drug Regulations : Online Resource for Latest Information
  44. 44.  The EU GMP guide  A single GMP guide is in use in the European Union.  See Link  The guide is referenced in the EU legislation ◦ Directives 2001/83/EC for human products, ◦ 2001/82/EC for veterinary products and in clinical trial legislation ◦ See Link  This has long since replaced any previously existing national GMP guide.  The EU GMP guide provides the standards and requirements used by EU inspectors for any GMP inspections ◦ Both in or outside of the European Union. 10/17/2015 44 Drug Regulations : Online Resource for Latest Information
  45. 45.  The EU GMP guide  The guide is subdivided into tree parts and 19 annexes dealing with specific types of manufacture.  Part 1 is the GMP for finished products  Part 2 GMP for active substances  Part 3 includes GMP-related documents  The EU GMP guide is harmonized with the PIC/S GMP guidelines on an ongoing basis.  EU GMP Part 2 reflects the EU’s agreement to the ICH Q7 guidelines and forms the basis of the detailed guidelines.  The Compilation of European Union Procedures on Inspections and Exchange of Information 10/17/2015 45 Drug Regulations : Online Resource for Latest Information
  46. 46.  The Compilation of European Union Procedures on Inspections and Exchange of Information  The Compilation of European Union Procedures on Inspections and Exchange of Information (CoUPs) is a collection of procedures for GMP and Good Distribution Practice (GDP). ◦ See Link  This is applicable to all the inspectorates in the European Union.  It provides a tool to facilitate cooperation between EU Member States and a means to achieve harmonization. 10/17/2015 46Drug Regulations : Online Resource for Latest Information
  47. 47.  The Compilation of European Union Procedures on Inspections and Exchange of Information  The CoUP covers, ◦ The basis for national procedures that form part of the national inspectorates’ quality systems, ◦ How quality defects and noncompliance are handled and ◦ How GMP and GDP inspections are carried out and reported. 10/17/2015 47 Drug Regulations : Online Resource for Latest Information
  48. 48.  The Compilation of European Union Procedures on Inspections and Exchange of Information  The contents of the CoUP are constantly updated, developed and agreed,  This is coordinated by EMA, by representatives of the Inspectorates of each Member State, including those supervising the manufacture and import of veterinary medicinal products only.  Once agreed, they are adopted by the European Commission and then published on its behalf by the EMA.  Common Union formats for manufacturing and import authorizations, GMP certificates and for statements of non-compliance with GMP have been agreed and published in the compilation  EU competent authorities have implemented them in order to enhance communication, collaboration and co- operation between authorities.  This common format enables Member States to enter manufacturing, importing and distribution authorizations in the Union database, EudraGMDP  See Link 10/17/2015 48Drug Regulations : Online Resource for Latest Information
  49. 49.  The GMP/GDP Inspectors Working Group  The GMP/GDP Inspectors Working Group (GMDP IWG) is a group of senior inspectors appointed by all the EEA competent authorities. ◦ SEE LINK  They meet at EMA premises four times a year  It is chaired by EMA  A European Commission representative attends the meetings,  Also observers from the European EDQM accession countries (countries which have applied to be part of the EU but have not joined yet) and MRA partners attend the meeting.  Representatives from other international authorities can be invited on a case-by-case basis 10/17/2015 49 Drug Regulations : Online Resource for Latest Information
  50. 50.  The GMP/GDP Inspections Working Group  The group is a forum for harmonization and discussion of common issues which are taken by the inspectors back to their NCA for implementation.  Any new or amended text of the EU GMP guide is developed by this group, with the European Commission responsible for the final adoption.  The GMDP IWG also maintains the CoUP and oversees, on behalf of the Heads of Medicines Agencies (HMAs) the Joint Audit Programme. 10/17/2015 50 Drug Regulations : Online Resource for Latest Information
  51. 51.  Training  The GMDP IWG organises training for EEA inspectors and inspectors from accession countries, aimed at raising the technical capability of the inspectors,  This ensures common understanding of issues related to GMP and harmonization.  In addition, EMA has signed a partnership agreement with PIC/S on cooperation on training for GMP inspectors, which recognizes the role that PIC/S plays in this area and avoids duplication of effort.  See Link 10/17/2015 51 Drug Regulations : Online Resource for Latest Information
  52. 52.  Ensuring Equivalence before Joining the EU  Becoming a member of the European Union is a complex procedure  There are strict conditions for EU membership to ensure that new members are admitted only when they are fully able to take on the obligations of membership,  This includes compliance with all the EU’s standards and rules.  For the purpose of accession negotiations, these are divided into 35 different policy fields (chapters). Link  For acceding to the EU, a candidate country must implement the EU rules and regulations in all areas.  The length of the membership negotiations can vary and depends on the time needed to complete the necessary reforms and the alignment with EU law.  The candidates are supported financially, administratively and technically during this pre-accession period. 10/17/2015 52 Drug Regulations : Online Resource for Latest Information
  53. 53.  Ensuring Equivalence before Joining the EU  In order to ensure that new Member States joining the European Union have reached the same level as the other members before the date of accession, a number of measures are put in place. These include: ◦ The European Commission checks compliance with the EU legislation (including pharmaceutical legislation) ◦ Through the TAIEX program (Link) financed by the European Commission, technical support may be provided ◦ Accession countries are invited as observers to EU meetings (including the GMDP IWG) ◦ Specific training on EU procedures is organized 10/17/2015 53 Drug Regulations : Online Resource for Latest Information
  54. 54.  Auditing is an important part of the measures put in place in order to oversee the equivalence of Member States.  There are a number of contexts in which Member States NCAs and/or inspectorates can be audited.  The Joint Audit Program (JAP) of the EU NCAs’ GMP inspectorates is an internal audit program under the Heads of Medicines Agencies (HMA) ◦ Link  This is run on behalf of HMA by the GMDP IWG.  JAP aims at achieving and maintaining equivalence between Member States’ national inspectorates responsible for GMP.  It was established in October 2000 and is an important part of the quality system adopted by all GMP inspectorates in the EU. 10/17/2015 54 Drug Regulations : Online Resource for Latest Information
  55. 55.  JAP auditors are senior GMP inspectors, further qualified for auditing inspectorates through specific training.  A list of qualified JAP auditors is maintained by the Compliance Group, which is a subgroup of the GMDP IWG.  Link  JAP auditors also provide technical advice and support to accession countries before they become EU Member States.  EU inspectorates are audited through the JAP onsite, at intervals established through a risk-based approach (typically every five to six years).  Mutual Recognition Agreement and other international partners are invited on a case-by-case basis to join JAP audits of EU Member States inspectorates as observers. 10/17/2015 55 Drug Regulations : Online Resource for Latest Information
  56. 56.  Audits are also organized in the framework of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ,jointly referred to as PIC/S and Mutual Recognition Agreement (MRA  See Link  Since most of the EU authorities and all MRA partners are member of PIC/S, synergies between the various audit schemes are used in order to avoid duplication. 10/17/2015 56 Drug Regulations : Online Resource for Latest Information
  57. 57.  The Benchmarking of European Medicines Agencies  See Link  (BEMA) is an internal EU program managed by the Heads of Medicines Agencies,  This is based on assessment of the systems and processes in individual agencies against a set of indicators in four main areas: ◦ Management systems ◦ Assessment of marketing authorization applications ◦ Pharmacovigilance (drug safety) activities ◦ Inspection services  The assessment identifies strengths and best practices in agencies and any opportunity for improvement.  The program has concluded its third cycle in 2015. 10/17/2015 57 Drug Regulations : Online Resource for Latest Information
  58. 58.  The European Union and its Member States are involved in several bilateral and multilateral cooperation activities with international partners in the GMP area.  The main advantage is that international cooperation allows, by relying on information received from trusted international authorities, to reallocate foreign inspections towards areas more at risk.  It thus optimizes available inspection resources. 10/17/2015 58 Drug Regulations : Online Resource for Latest Information
  59. 59.  PIC/S  Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme  Jointly referred to as PIC/S  http://www.picscheme.org/pics.php  Aims at harmonizing inspection procedures worldwide  Develops common standards in the field of GMP  Provides training opportunities to inspectors.  Facilitates cooperation and networking between competent authorities, regional and international organizations.  Most EU Member States are members of PIC/S while EMA is participating 10/17/2015 59 Drug Regulations : Online Resource for Latest Information
  60. 60.  Mutual Recognition Agreements ( MRA’s)  Link  Official agreements on the mutual recognition of assessment of conformity of regulated products, which are negotiated and signed at EU level.  MRAs concluded by the European Union include pharmaceuticals and cover GMP.  Consequently, inspection results carried out by MRA partners in their territory are recognized by EU Member States and vice versa  Retesting upon importation into the European Union is not needed in the QP batch certification process.  The MRA scope can cover both human and veterinary products, finished products, active substances and Investigational Medicinal Products. 10/17/2015 60 Drug Regulations : Online Resource for Latest Information
  61. 61.  There are differences in scope between the various MRAs.  Currently, the European Union has operational MRAs in place with Australia, Canada, Japan, New Zealand and Switzerland.  The EU also has in place an Agreement on Conformity Assessment and Acceptance of industrial products (ACAA), which includes GMP, with Israel.  An ACAA is a specific type of MRA;  The main practical difference is that in the ACAA case results of inspections carried out outside the territory of the agreement partners are mutually recognized as well, in addition to inspections carried out in the partners’ territory.  An MRA between the European Union and the United States was signed in 1999; at the time of this writing it is operational only toward rapid alerts. 10/17/2015 61 Drug Regulations : Online Resource for Latest Information
  62. 62.  International Coalition of Medicines Regulatory Authorities (ICMRA).  Link  The European Commission, EMA and some EU Member States participate to the activities of the International Coalition of Medicines Regulatory Authorities ◦ (France, Germany, Ireland, Italy, Spain and UK)  Recent initiative  Started by Heads of Medicines Agencies worldwide,  Aims at providing global strategic coordination and direction on areas that are common to many regulatory authorities’ missions worldwide,  Builds on existing arrangements such as those of PIC/S.  The ICMRA has the objective to establish synergies and to foster global cooperation among regulators and GMP is one of the ICMRA main areas of interest. 10/17/2015 62 Drug Regulations : Online Resource for Latest Information
  63. 63.  Other International Cooperation Activities  In addition to MRAs, the European Union is involved in several less formalized cooperation schemes on GMP with international partners and/or in areas not covered by an MRA  API international cooperation project  Main objectives are the sharing of information on inspection planning, policy and inspection reports and joint inspections on manufacturers located outside the participating countries.  It includes the following participants:  The EMA and all EU member States, the European EDQM, the U.S. FDA, the Australian Therapeutic Goods Administration (TGA) and WHO. 10/17/2015 63 Drug Regulations : Online Resource for Latest Information
  64. 64.  Several bilateral pilots and programs between EMA and FDA were also developed during the last ten years with the view to increase collaboration on domestic and third country GMP inspections.  This less formal form of cooperation in the last years has allowed the building of confidence among cooperating countries and regions, mainly through joint inspections and exchange of information  Link  It is opening new possibilities of mutual reliance on inspection results.  In this perspective, it is worth noting that the European Union has identified the recognition of GMP inspections carried out in the European Union and the United States and in third countries as a main objective for the pharmaceutical sector in the context of the negotiations of the Transatlantic Trade and Investment Partnership  Link 10/17/2015 64 Drug Regulations : Online Resource for Latest Information
  65. 65. This presentation is compiled from freely available resource like the website of EMA & EU. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional. Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals. 10/17/2015 65 Drug Regulations : Online Resource for Latest Information

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