Strengthening Capacity to Improve Medicine Regulation in Asia
Biologicals―a class of drugs produced using a living system such as a plant cell or animal cell―are different from medicines that are chemically produced. The manufacturing of biological products, including vaccines, requires extensive testing at each stage of production to ensure quality, safety, efficacy, and consistency among batches. Even minor changes in manufacturing may lead to significant changes in quality, which has the potential to put end users at risk. Because of this, specific regulatory guidance on biologicals/biosimilars is continuously evolving.
With support from the USAID Asia Bureau, the USAID MTaPS and Promoting the Quality of Medicines Plus (PQM+) programs hosted a five-day training of trainers on product evaluation for registration of biologicals, including vaccines, on December 5–9, 2022. The aim was to enhance the knowledge of national regulatory authority (NRA) staff about global regulatory requirements that must be considered during product registration and evaluation to sustainably strengthen medical products quality assurance systems.
NRAs oversee the regulation of medical products, including the registration or marketing authorization process, and the training targeted representatives of NRAs in the Association of Southeast Asian Nations (ASEAN). Invited participants had specific roles and responsibilities related to biological product registration, evaluation, and market authorization. Twenty-five NRA staff from nine ASEAN member states (with the exception of Singapore) participated in the training to gain the skills and knowledge necessary to ensure continuing evidence for the quality, safety, and efficacy of the life cycle of the products they regulate.
Using a highly interactive approach, the training equipped participants with knowledge and understanding of assessing biologics and vaccines, particularly for COVID-19 vaccines. Participants came away with a clear understanding of the guidelines used by regulatory authorities in ASEAN countries and internationally, knowledge about the current regulatory framework and key quality standards for evaluating biologics, and the advantages of converging technical standards among ASEAN member states.
In his closing remarks at the end of the training, Jean-Jacques Frere, Senior Health Advisor in the Asia Bureau of USAID, said, “We are grateful that with the support of our MTaPS and PQM+ projects, USAID can coordinate with ASEAN countries to promote uniform regulatory requirements and optimize medical product manufacturing capability at the country and regional level, and ensure the highest levels of safety and quality standards.”
Participants gained access to materials and resources to train their fellow staff and will offer expertise regionally to promote uniform application of technical standards for the registration of biologics and vaccines. They will further contribute to enhancing NRA proficiency for evaluation toward improved access to safe, effective, quality-assured medicines and vaccines, building confidence and trust among NRAs in the ASEAN regional block, and improving patient safety.