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HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.
On Nov. 20, 2020, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.
In the joint statement, the regulatory authorities specify that the majority of COVID-19 vaccines are included within the scope of the centralized procedure, as per European Union legislation (Regulation 726/2004), as the vaccines are produced using biotechnological processes. For cases where the vaccine under development is composed of a whole-inactivated virus or live attenuated virus, HMA and EMA are also recommending that marketing authorization holders follow the centralized procedure so that, should the vaccine be approved, it will be available to all member states simultaneously.
It is possible for companies to submit authorization applications through a centralized procedure even when the vaccine does not fall under the scope of the legislation as the medical product is either considered to be significantly innovative, scientifically or technically, or will benefit patients in the union through authorization. EMA’s Committee for Medicinal Products for Human Use (CHMP) will be responsible for performing the scientific assessment of applications that are not within the scope of the centralized procedure and will provide its recommendation on whether authorization should be granted or not by the European Commission.
“In accordance with predefined standards for quality, safety, and effectiveness that adequately protect EU patients and all people who receive medicines or vaccines, EMA in close cooperation with NCA experts in scientific committees, uses accelerated procedures to speed up the process. The goal is to deliver assessments of high-quality applications in the shortest possible timeframes while ensuring robust scientific opinions. Therefore, COVID-19 vaccine applications should be assessed via the centralized procedure and, in addition to the centralized procedure itself, EMA’s scientific advice mechanism should be used whenever necessary, to advise developers on the quality, safety, and efficacy requirements that must be met to enter the European market,” EMA and HMA stated in the press release.