Organization Project Objective Activities Where
PAHO Pan American Network for Drug Regulatory harmonization To maintain a constructive dialogue among drug regulatory authorities and other stakeholders, adopt guidelines on specific aspects of regulation, and promote technical cooperation among countries. Harmonization and capacity building efforts in:

• Bioequivalence

• Biotechnological products

• Counterfeit medicines

• Good clinical, laboratory, and manufacturing practices

• Medicine manufacturing plants

• Medicines classification and registration

• Pharmacopeia

• Pharmacovigilance

• Vaccines

The Americas
APEC APEC Harmonization Center Increase regulatory harmonization among member states with the goals of supporting access to best practices, information exchange, and clinical trials that meet international standards and to improve the quality, safety, and efficacy of medical products to enhance health outcomes and facilitate international trade.

• Research on harmonization policies and best practices

• Education and training, including fellowship programs

• Establish strong information exchange networks

• Maintain online publications

• Develop and disseminate harmonization models

• Support international cooperation

Asia Pacific
ASEAN ACCSQ Pharmaceutical Product Working Group The harmonization of pharmaceutical regulations to facilitate the goals of the ASEAN Free Trade Area, particularly eliminating technical barriers to trade, without compromising the quality or safety of medicines.

• GMP training

• Implementation of common technical requirements

• Mutual recognition agreements for GMP inspections

• Shared postmarket surveillance information

• Vaccine regulation capacity building

Southeast Asia


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