A global approach to regulatory flexibility to increase manufacturing capacity during COVID-19
Open dialogue between regulators and companies, better product and process knowledge, good manufacturing practice (GMP) compliance, and an effective pharmaceutical quality system are the main ingredients to facilitate regulatory decision-making for increased manufacturing capacity for COVID-19 therapeutics and vaccines post approval. The International Coalition of Medicines Regulatory Authorities (ICMRA) has outlined these principles in a statement on pre-requisites for regulatory flexibility that can be applied to increase manufacturing capacity and supply globally.
“We can be proud of how regulators and the research community around the world have risen to the COVID-19 challenge. We have applied extraordinary measures in different areas of medicine regulation to ensure continuity of medicine supply and demonstrated that the regulatory system is capable of adapting in light of the medical emergency presented by COVID-19,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “Going forward, we have to build on the lessons learnt during the COVID-19 pandemic in a way that is sustainable for regulators. This could include changes to existing paradigms where needed and maximising synergies, especially by increasing collaboration, co-operation and reliance amongst authorities.”
The joint statement was developed following a workshop on expansion of manufacturing capacity for COVID-19 therapeutics and vaccines organised by ICMRA in July 2021. More than 400 delegates from over 30 medicines regulatory authorities globally, as well as experts from the pharmaceutical industry, discussed manufacturing challenges and harmonising regulatory approaches to enable rapid increases in manufacturing capacity for COVID-19 treatments and vaccines. A meeting report highlighting the outcomes of the discussions is available on the ICMRA website. A follow-up meeting will be organised in the coming months.