anti-counterfeit

1、 Follow-up of the Recommendations made at the 9th International Conference of Drug Regulatory Authorities (ICDRA), 1999Lembit Rgo, MD, PhD, CoordinatorQuality Assurance and Safety: MedicinesEssential Drugs and Medicines Policy Health Technology and Pharmaceuticals ClusterWorld Health OrganizationE-m

2、ail: ragolwho.ch3rd Pan American Conference on Drug Regulatory Harmonization24-26 April 2002,Washington, D.C., USAInternational Conference of Drug Regulatory Authorities (ICDRA)An unique forum where regulators from both developing and developed world gatherICDRA has been held every two years since 1

3、9809th ICDRA was held in Berlin, Germany in April 1999, with 280 participants from 90 countriesObjectivesPromoting collaboration between national drug regulatory authoritiesAchieving a consensus on matters of mutual interestFacilitating timely and adequate exchange of technical informationDiscussing

4、 topical issues of international relevanceMany important World Health Assembly Resolutions have originated in ICDRATopics of 9th International Conference of Drug Regulatory Authorities (ICDRA) (I)Good Regulatory PracticeGood Certification PracticeCounterfeit drugs: Challenges and solutionsCurrent is

5、sues in regulation and qualityICH: Implementation and ImplicationsICH: Common technical document Drug utilization studiesGlobal and national efforts to reduce tobacco useTopics of 9th International Conference of Drug Regulatory Authorities (ICDRA) (II)Electronic communication in the regulatory proce

6、ssTransparency in monitoring the safety of medicines Pharmaceutical products for use in special populationNeed for bioequivalenceAntimicrobial resistanceSafety of plasma-derived medicinal productsHerbal medicinesRegulation and access to essential drugs9th ICDRA- Recommendations and their follow-up R

7、ecommendations were made at the each sessionRecommendations to WHORecommendations to national drug regulatory authoritiesFollow-up of the recommendations to WHOWhat has WHO achieved since then?What are the obstacles to implement the recommendations?What needs to be done further?What is the Impact of

8、 WHOs work on drug regulatory authorities?10th ICDRA will be held in Hong Kong, Special Administrative Region of China, from 24-27 June 2002 Good Regulatory Practice Recommendations to WHOWHO should develop guidelines to define good regulatory practice and develop appropriate indicators to measure p

9、erformance. These guidelines should be made available over the WHO website to enable countries to formulate their own standard operating procedures (SOPs). Good Regulatory Practice What has been achieved?A Multicountry study on effective drug regulation (10 countries in total) was carried out to com

10、pare country experience and it includes concepts, methods and indicators for assessing regulatory performance (The final text is in press and will be available soon on the WHO website) (/medicines/) The joint initiative between EDM/QSM and VAB/ATT to visit countries and assess the r

11、egulatory capacities for both drugs and vaccines was launched. Guidelines to assess the regulatory capacities (Rapid Assessment Tool) will be developed, which will help develop a strategic work plan to strengthen national authorities Good Certification Practice Recommendations to WHOWHO should conti

12、nue to promote the use of the Certification Scheme with a view to assuring its global applicationWHO should trigger feedback information on the practical utility of the Scheme, including the certification needs of importing countries, ways to prevent falsification of certificates, and how to improve

13、 the effectiveness of the SchemeWHO should work with national authorities to develop appropriate, safe and reliable mechanisms to permit exchange of verifiable product certificates and information on the InternetGood Certification Practice Recommendations to WHO (cont.)WHO should foster further deve

14、lopment of the Certification Scheme to: (a) include provisions for additional information on manufacturers, and (b) address the case of products with no marketing authorization in the certifying country. A declaration by the companys authorized person before the certifying country authority, includi

15、ng information on product development, stability testing, and prior marketing should be givenGood Certification Practice What has been achieved?World Health Assembly Resolution on the Revised Drug Strategy in May 1999 (WHA52.19) requested WHO to prepare a new scheme for the certification of starting

16、 materials in international commerceThe draft of the guideline and the model certificate for the starting materials was discussed at the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2001Counterfeit drugs: Challenges and solutions Recommendations to WHO Liaison of

17、ficers of the WHO anti-counterfeit drugs network should be utilized for information exchange and investigation of counterfeit drugs. The draft WHO guidelines for the development of measures are useful instruments and will be made available on the WHO website. International cooperation should be stre

18、ngthened and involve international agencies such as WHO, UNICEF and Interpol. WHO and Interpol should develop initiatives to improve the exchange of information. International agencies should give specific consideration to the conflict between the need for regulatory authorities to know of the circu

19、lation of counterfeit products and the need for confidentiality when criminal investigations are under way. Counterfeit drugs: Challenges and solutions What has been achieved?“Guidelines for the development of measures to combat counterfeit drugs” and “Counterfeit and substandard drugs in Myanmer an

20、d Viet Nam” were published Materials (poster, videotape, booklets) to raise awareness of the problems were preparedWorking Group which includes international pharmaceutical associations and NGOs were createdWorkshops and meetings on counterfeit drugs involving industry and international agencies hav

21、e been organized regularly at international / regional levelTraining workshops for regulators have been organizedCurrent issues in regulation and quality Recommendations to WHOWHO should:Continue to serve as a platform for the exchange of information on important regulatory decisions of worldwide im

22、plication Take measures to reinforce the collaboration between drug regulatory and criminal investigation authorities internationally, in particular Interpol and the World Customs Organization, to deal with criminal activities involving pharmaceutical products and materialsImplement recommendations

23、on safe trade and control of starting materials as set out in document WHO/PHARM/98.605, including risk assessment of starting materials. Current issues in regulation and quality Recommendations to WHO (cont.)WHO should:Develop safe trading practices in close collaboration with brokers, traders and

24、other international organizations and institutionsSupport training of assessors for new drug applications and good manufacturing practice (GMP) inspectors in countries with limited resources, in collaboration with national health authoritiesCurrent issues in regulation and quality What has been achi

25、eved?The draft guideline and the model certificate of WHO Certification Scheme for the starting materials was discussed at the WHO Expert Committee (EC) on Specifications for Pharmaceutical Preparations in October 2001Draft of Good Trade and Distribution Practices (GTDP) of pharmaceutical starting m

26、aterials was discussed at the ECThe WHO basic training modules on GMP (CD-ROM) was developed and several training workshop for inspectors were heldTraining workshops for assessors of drug applications were held in Africa and AsiaICH: Implementation and implications Recommendations to WHOWHO should c

27、ontinue to play an important role by taking into account the implications for non-ICH members. WHO should explore the feasibility of integrating ICH products and WHO guidelines into a comprehensive set of guidelinesSince ICH guidelines cover new products and many countries manufacture, register and

28、use generic drugs, WHO is encouraged to continue work on guidelines on requirements for registration of generic drugsICH: Implementation and implications What has been achieved?An independent review team was convened to assess the implications of ICH on non-ICH countries and options for the future r

29、ole of WHO were proposed: result article in WHO Drug Information vol. 14, No.3, 2000 Based on the above, an informal consultation was held to discuss considerations on the Impact of ICH in non-ICH member countries(September 2001, the report is in press)Review of WHO-GCP has been initiated to explore

30、 the harmonization with other guidelines including ICH-GCPThe discussion summary of the ICH meetings have been disseminated to non-ICH countries to receive more feedbackDrug utilization studiesRecommendations to WHOWHO should assist drug regulatory authorities by:Encouraging studies of actual use an

31、d consumption of drugs by relating pharmacotherapy to the actual diseasePromoting quality of the data by ensuring that the source of the data is accurate and establishing a system of data collection Raising awareness of how Anatomic- Therapeutic-Chemical (ATC) and Defined Daily Doses (DDDs) are deve

32、loped through educational programmes in order to prevent misinterpretation and misuse of ATC/DDD. Drug utilization studiesRecommendations to WHO (cont.)WHO should assist drug regulatory authorities by:Adopting or adapting manuals for use of the ATC/DDD classification at local level with reference to

33、 the manuals prepared by the WHO Collaborating Centre on Drug Statistics Methodology in Oslo, Norway Promoting greater awareness of changes in the ATC/DDD classification system and establishing conditions for the regular updating of national classification systemsDrug utilization studiesWhat has bee

34、n achieved?Several studies on the use of antimicrobials and antihypertensive drugs have been carried out and will soon be publishedA manual entitled, “Introduction to Drug Utilization Research” is in press (2002)A regional training course for regulators and other users of the system is being planned

35、 in October 2002 (“The application of ATC/DDD methodology in drug utilization research”)Electronic communication in the regulatory processRecommendations to WHOWHO should set up an electronic communication system to permit effective, prompt and secure Information exchange among drug regulatory autho

36、ritiesWHO should further promote the implementation of computer-assisted drug registration in order to contribute to effective drug regulationElectronic communication in the regulatory processWhat has been achieved?WHODRA Electronic Discussion Group was established as a tool for communication among

37、national drug regulatory authorities and WHO, however, it was deemed impossible to have a closed discussion after some experiencesWHO has been working with the European Medicines Evaluation Agency (EMEA) on a new version of Model System for Computer-assisted Drug Registration (SIAMED), which will be

38、 ready in late summer 2002. A user guide is under development.Transparency in monitoring the safety of medicinesRecommendations to WHONetworks for electronic exchange of drug information, in particular relating to safety and which allow for rapid communication, should be established. WHO should take

39、 the lead in this endeavourPrinciples of good communication should be developed by WHO with input from WHO Member States and regional authoritiesTransparency in monitoring the safety of medicinesWhat has been achievedMore information on website, immediate postingWHO Collaborating Centre for Internat

40、ional Drug Monitoring (UMC) in Uppsala, Sweden has created a “Vigimed” network in which all representatives of National Pharmacovigilance Centres that have an e-mail address are included. It is being used for rapid distribution of drug safety alerts and general information exchangeA document which d

41、iscusses the principles of good communication in pharmacovigilance and the roles of various players is in press with the help of the UMCWHO Pharmaceuticals Newsletter merged with UMCs Adverse Reactions Newsletter for wider and more effective dissemination of safety information - available on website

42、Need for bioequivalenceRecommendations to WHOWHO should:Develop common definitions and guidelines indicating when in vivo equivalence studies are neededCoordinate the development of model guidelines for harmonization purposes to determine when in-vitro studies are acceptableMake the list of internat

43、ional comparator products widely available, including advice on how it can be used by drug regulatory authorities within their national context for viral and other transfusion transmitted diseasesNeed for bioequivalenceRecommendations to WHO (cont.)WHO should:Take the lead in identifying where there

44、 is a need for training in each region and arrange for access by drug regulatory authorities and interested partiesDevelop and promote the introduction of appropriate guidelines for the accreditation of drug quality control laboratoriesNeed for bioequivalenceWhat has been achieved?Provisional list p

45、ublished in WHO Drug Information, list of international comparator products with the note on how it can be used is in pressWHO has decided to review the “Guidelines on Registration Requirements to Establish Interchangeability” (based on the recent thinking on the establishment of interchangeability,

46、 including inter alia, Biopharmaceutical Classification System” set out in the US FDAs guidance and other evidence available) Antimicrobial resistanceRecommendations to WHO WHO is invited to:Bring together national authorities for human and veterinary drug regulation to exchange information and to c

47、onsider Joint actionProvide guidance on the clinical development of antimicrobial drugs, in particular to optimize efficacy while minimizing the risk of resistanceEstablish a common format for product information and patient information leaflets, specifically addressing antimicrobial resistance issu

48、es Special attention should be given to improving the communicative potential of the information provided. This information should be regularly updated in the light of prevailing resistance patternsAntimicrobial resistanceRecommendations to WHO (cont.) WHO is invited to:Continue efforts, as set out

49、in WHO resolution WHA 51.17, to make antimicroblal drugs available on a prescription-only basIsStimulate drug regulatory authorities to share all relevant information on clinical trials involving antimicrobial drugs, with public health authoritiesAntimicrobial resistanceWhat has been achieved? The W

50、HO global strategy for containment of resistance was launched in September 2001The exchange of information programme among drug regulatory authorities is being enhancedThe WHO Model Prescribing Information - Drugs used in Bacterial Infections providing clinical information on antimicrobials was publ

51、ished in 2001Safety of plasma-derived medicinal productsRecommendations to WHOWHO should:collaborate with Member States to strengthen the technical expertise of national control authorities in the regulation of plasma productsPromote the regulation of blood bank facilities by National Control Author

52、ities in order to ensure compliance with GMP principlesFacilitate the development of educational programs and training opportunities for National Control Authorities involved in regulation and control of blood products. WHO should promote regional cooperation and trainingSafety of plasma-derived med

53、icinal productsRecommendations to WHO (cont.)WHO should:Assist Member States in the development of appropriate guidelines for plasma fractionation contract activitiesProvide guidelines on information to be included in batch release certificates in order to facilitate acceptance of imported plasma pr

54、oducts by national control authoritiesSafety of plasma-derived medicinal productsWhat has been achieved? “The WHO Guidelines on Viral Inactivation and Removal Procedures Intended to Assure the Viral Safety of Human Blood Plasma Products” were established in November 2001“Global Project for Quality Assurance and Safety of Blood Plasma Derived Medicinal Products” was initiated.A WHO Regional Workshop on Quality Assurance and Safety of Plasma Derivatives was organized in PAHOAn Aide Memoire on Blood Products and other Biologicals and Information Sheets for Regulato