Areas: Medicine regulation and quality assurance
Activities
- Medicine legislation and regulation: Support is provided to member countries in need to establish drug regulatory systems and relevant medicine legislation. Assessment of drug regulatory capacity is undertaken in some member countries to identify needs for improvement. Training for drug regulatory authorities in countries with more established systems is continuously undertaken.
- Quality assurance: WHO advocates the adoption of the international guidelines of Good Manufacturing Practices (GMP). National training in GMP is organized in different countries. Support for improving the capacity of national pharmaceutical quality control laboratories is provided.
- Combating counterfeit and substandard medicines: WHO works with partners and Member States to strengthen the collaboration between medicine regulators and law enforcement agencies in combating counterfeit and substandard medicines.
Main activities in 2010-2011
- The WHO/INTERPOL joint Operation STORM 2 has been completed during the final meeting in January 2011. Three (3) Mekong countries completed their participation in the INTERPOL/WHO joint operation STORM to combat counterfeit medicines. WHO participates and supports enforcement network lead by Interpol to improve collaboration between medicines regulatory authorities and law enforcement agencies in Mekong countries and South- East Asia (Cambodia, China, Lao People's Democratic Republic, Malaysia and Philippines)
- Experts from six (6) Member States (Australia, Cambodia, Japan, Lao People's Democratic Republic, Malaysia and Philippines) and three (3) partners organizations (INTERPOL, USP and MSH) participated in an Expert Consultation on the Surveillance and Rapid Alert System for Counterfeit Medicines (February, 2010) in Manila. As one of its follow up, the regional Rapid Alert System for Combating Counterfeit Medicines (RAS) has been revised.
- Eight (8) Member States (Cambodia, Mongolia, Lao People's Democratic Republic, Fiji, Papua New Guinea, Philippines, Tonga and Viet Nam) were supported to participate in the 14th ICDRA (International Conference of Drug Regulatory Authorities), in
December 2010, Singapore.
- Sixteen (16) Member States participated in a Meeting of Medicines Regulators from the Western Pacific Region (4 December 2010) in Singapore, to facilitate information exchange between/with regulators in the Western Pacific Region, and to increase awareness on selected technical and regulatory developments (Australia, Brunei Darussalam, Cambodia, China, Fiji, Hong Kong, Korea, Lao People's Democratic Republic, Malaysia, Mongolia, New Zealand, Papua New Guinea, Philippines, Singapore, Tonga and Vanuatu).
- Seven (7) Member States (Cambodia, China, Lao People's Democratic Republic, Malaysia, Mongolia, Philippines and Viet Nam) attended the interregional workshop on Combating Substandard/Spurious/Falsely labeled/Falsified, Counterfeit medicines in October 2011.
- Good Governance for Medicines has been implemented in 4 Member States (Cambodia, Malaysia, Mongolia and Lao People's Democratic Republic) while one Member State (Philippines) is implementing META.
- Prequalification project has been successfully implemented in China.
- Two (2) Member States (Vanuatu and Viet Nam) were supported to assess and set up a pharmacovigilance system.