14 th International Conference of Drug Regulatory Authorities : Progress report from the Western Pacific Region

Transcription

1 14 th International Conference of Drug Regulatory Authorities : Progress report from the Western Pacific Region Budiono Santoso Team Leader Essential Medicines & Technologies, World Health Organization, Western Pacific Regional Office, Manila, the Philippines.

2 WHO Western Pacific Region 37 countries and areas with extreme diversity in development stages, demographic, socio-economic, and geographical conditions. Countries with sizable pharmaceutical industries : Australia, China, Japan, Korea, Malaysia, Philippines, Singapore, Viet Nam. Geographical groups : ASEAN Mekong countries Pacific island countries.

3 Existing programs relevant to the 13 th ICDRA recommendations Essential Medicines & Pharmaceutical Policies Traditional Medicines Health Technologies & Laboratories International Health Regulation Immunization.

4 Essential Medicines & Pharmaceutical Policies Program National medicine policies & access to essential medicines. Medicines regulation, quality assurance & combating counterfeit and sub standard medicines. Quality (or rational) selection and use of medicines.

5 Activities & achievements in medicines policies & access (1) Regional access strategy Review the Regional Access Strategy Develop the Regional Framework on Access Regional Price Information Exchange for Essential Medicines Round one covering 18 countries. Pricing policies & monitoring Malaysia, Viet Nam National medicines policy - development, assessment & revision Brunei, Cambodia, Malaysia, Mongolia, Philippines, PICs : Cook, Fiji, FSM, Marshal island, Samoa, Solomon, Tonga & Vanuatu. Preparation of the Asia Pacific Conference on National Medicines Policy in Strategic plan for (universal) access & health reform CHN, Malaysia, Viet Nam. WHO/EC/ACP Partnership on Pharmaceutical Policies and Access to Essential Medicines for 14 Pacific island countries. Final evaluation mission in July 2010.

6 Activities & achievements in medicines policies & access (2) Country profile on medicine sector CHN International training courses on procurement, supply & management Decentralized environment (Yogyakarta, Indonesia, Oct. 08) Pacific island countries ( Melbourne, July 09) Intercountry & country consultations on TRIPS agreement & access to medicines CHN, Cambodia, Laos, Viet Nam, Philippines, Pacific countries Medicines expenditure reviews (total 9 countries) Fiji, Samoa, Solomon, Tonga, PNG, Vanuatu Cook Islands, Marshall Islands, Nauru & Tuvalu. Pediatric & maternal medicines Monitoring availability in Viet Nam Strategy for Improving Essential Medicines for MCH (Viet Nam, Dec 2010) SFDA/WHO/FIP - Training workshop on development pediatric formulation (Beijing, June 10) WHO/UNFPA joint assessment on availability of reproductive health medicines Laos, Mongolia, Philippines, Solomon and Vanuatu.

7 Regional price information exchange for selected medicines

8 Figure 1. Progress in the development/revision of the NMP in the Western Pacific Region Number of countries Existence of NMP (official or draft) NMP official document Implementation plan updated in last five years NMP integrated in National Health Plan

9 Activities & achievements in medicines regulation and quality assurance (1) Operation STORM 1 & 2 for combating counterfeit medicines. Cambodia, China, Laos, Indonesia, Myanmar, Singapore, Thailand, Viet Nam, WHO, WCO and INTERPOL. Network for regulators & law enforcement agencies Technical support for medicines registration China, Cambodia, Mongolia etc. Pharmaco-vigillance centre Cambodia, Viet Nam Inter-country & country training courses on pharmacovigillance. Manila (Sept 08), Singapore, Hanoi (Dec 2010), Cambodia. Medicines surveillance involving consumers Malaysia, PHL Common approach in medicines quality assurance in PICs. Training on GMP : CHN, Laos, Viet Nam.

10 Activities & achievements in medicines regulation and quality assurance (2) Review of combating counterfeit activities & revision of the regional Rapid Alert System (RAS). Prequalification project in CHN funded by Gates and GFATM. Joint mission with UNIDO on local production to Viet Nam. Joint mission with ADB on medicines regulatory infrastructure to Mongolia. Assessment of NRA for vaccines China (including for H1N1) Viet Nam.

11 Revising the Regional Rapid Alert System (RAS) for combating counterfeit medicines - A web networks launched in Designated focal points from 38 countries/areas & agencies. 175 accepted reports Cambodia, Mongolia, PHL, France, Nepal & others

12 Figure 5. Progress in medicines registration in the Western Pacific Region Number of countries Provision of Marketing Authorization Marketing Authorization list publicly available Computerized system for registered products

13 Activities & achievements in promoting rational use of medicines (1) EML & STGs Review of EML & STGs in 12 Pacific countries & Cambodia Establishment of drug committee in Brunei, China, Mongolia, Viet Nam. Pacific working group meeting for medicines selection and use (Suva, July 09) ASEAN training course on pharmaco-economics in Brunei (Dec 08). Evidence based medicines selection National training course in China (Sept 09). Development of operational manual ( Viet Nam)

14 Activities & achievements in promoting rational use of medicines (2) National training on rational use & advocacy on AMR Cambodia, Cook, Fiji, Samoa, Tuvalu, Tonga, Solomon. Collaboration with professional associations - FAPA & FIP FAPA/WHO workshop on the role of pharmacist in primary health care (Seoul, August 2010) WPR Pharm/WHO training on good pharmacy practice in VTN (2008) Focused intervention for rational use (monitoring training and planning) Cambodia, China, Laos and Mongolia. Be Safe with Medicines : Ensuring Medication Safety Practice in Viet Nam.

15 Good governance in medicines Participated in GGM phase 3 countries global meeting in Tunisia (June 2010). Malaysia, Mongolia & Philippines. Malaysia GGM framework in line with the National Integrity Plan. Conflict of interest policies. Transparency in procurement & registration. Mongolia Transparency in registration process through web Workshop on "promoting transparency and accountability in the health sector GGM framework introduced in the pharmacy curriculum & private sectors Conflict of interest declaration for Drug Committees incorporated in the law Philippines Manuals for good governance in registration, selection & procurement GGM awards for transparency & good governance in medicines supply management in the health facilities. Laos National workshop on ethical infrastructure.

16 Traditional medicines program Policies on TRMs safety, efficacy and quality Cambodia, Laos, Mongolia, Philippines Publication (in process) of medicinal plant monographs Mongolia, Lao PDR, PNG International Classification of Traditional Medicine ICD 11 chapter 23 : safety and quality of herbal medicines Development of Regional Strategy on TRM ( ).

17 Health technologies & laboratories program Asia Pacific Strategy for Strengthening Health Laboratory Services was endorsed in A coherent national framework with regulatory oversight mechanisms. Blood Bi-regional workshop on "Blood Donor management" (Hanoi, June 2010) To establish and strengthen voluntary blood donations to meet national requirements; To integrate the principles and practices of quality at all levels of the donation process; To utilize modern IT tools for blood donor databases WHO will provide technical support to develop generic standards for blood donor recruitment Medical devices Country assessment on regulation of medical devices

18 International health regulation National IHR focal points (NFP) participated Asia Pacific Technical Advisory Group on Emerging Diseases Annual progress review of IHR (2005) and the Asia Pacific Strategy for Emerging Diseases (APSED) Better communication between NFP and other government agencies during H5N1. 80 public health events have been reported by NFP to WHO since IHR Event information sites for sharing information on H1N1 pandemic. Medicines regulatory authorities are encouraged to coordinate with IHR national focal points on cases related to dangerous chemicals in food products & medicinal products (?)

19 Conclusion Collaboration in strengthening medicines regulation & quality assurance Human resource training Exchange of information and networking Combating counterfeit and sub standard medicines. Rapid alert system & exchange of information. Quality surveillance.

20 THANK YOU