Snapshot

The Emergency Use Authorization of COVID-19 Vaccines pathway has been developed by the of Bangladesh.

This pathway can be used where unlicensed vaccines in an emergency where minimal data is available.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia EU-EMA France Germany Japan Switzerland United Kingdom United States WHO

One of the key challenges in ensuring access to life-saving vaccines in Bangladesh is establishing pathways for authorizing COVID-19 vaccines for emergency use in a timely manner. COVID-19 vaccine EUA will be carried out following fast-track review pathway, either adopting reliance and recognition or through critical review. In Bangladesh, DGDA has 2 distinct regulatory EUA pathways which are depicted below: 1. Reliance and Recognition pathways. Regulatory reliance has emerged as an exciting and viable way to avoid duplication of review effort, ease the burden on under-resourced regulatory agencies, and still deliver new medicines to patients who need them. DGDA may totally or partially rely upon the evaluations performed by another NRA or trusted institution in reaching its own decision. The DGDA remains responsible and accountable for decisions taken even when it relies on the decisions and information of others. With strong collaboration among regulatory agencies, it may be possible to build upon existing frameworks and global standards, building trust and sharing resources and experiences. The basis of applying this pathway for those vaccines which got EUA/CMA registration in any of the 7 countries (USA, UK, Switzerland, Germany, France, Australia & Japan) or European Medicines Agency (EMA) and/or WHO Emergency Use Listing (EUL). The reliance and recognition pathways require submission of satisfactory evidence of required documents as per requirement of DGDA. 2. Critical review pathway. The “Public Health Emergency Committee (PHEC)” will review the submitted documents and make recommendations to DGDA. Based on the recommendation of the PHEC, DG, DGDA will decide whether the EUA will be granted or not. The proposed COVID-19 vaccines that go through this pathway are (a) The imported COVID-19 vaccines that are not listed by the aforementioned regulatory bodies/countries or WHO EUL, (b) Locally manufactured vaccines using imported bulk, (c) Locally produced vaccines through technology transfer (either from bulk or master seed), (d) Indigenous COVID-19 vaccine development.