The arrival of Covid-19 has placed health systems in countries around the world under a significant strain, pushing governments to introduce emergency measures to accelerate the response to the virus in the hope of the containment or, ideally, elimination of Covid-19. One measure implemented by a number of countries is fast-tracking the registration of drugs to treat Covid-19 using what is normally referred to as Emergency Use Authorization ("EUA").
The Indonesian Food and Drugs Supervisory Agency (Badan Pengawas Obat dan Makanan or "BPOM") announced on April 7, 2020, that it would follow other foreign food and drug agencies in accelerating the drug registration process using the EUA platform for any drugs with the potential to treat Covid-19.
Under the normal procedure it can take months or even years to complete the drug registration process due to the multiple layers of inspection and lengthy bureaucratic procedures. Significantly cutting back the time needed for drug registration may allow viable drug products to be accessible to Covid-19 patients, which could save lives and eventually help bring the pandemic to an end.
Accelerated drug registration has been implemented by BPOM in the past, but it has been largely adopted on a discretionary basis. Given the urgency of the Covid-19 outbreak, BPOM plans to formalize the procedure using the EUA platform in the coming days. In the meantime, in an official press release, BPOM provided the following brief guideline that may be useful to Indonesian pharmaceutical manufacturers in registering products with the potential to treat Covid-19.
Mechanism for Emergency Use Authorization
In the press release, BPOM emphasized that it would prioritize the registration of any drugs with a potential claim to treating Covid-19. This includes the registration of any new drugs or existing drugs being repurposed for Covid-19 treatment.
The pharmaceutical manufacturing company, acting as the registrant for the product, would need to submit, among others, information and documents on:
- Pilot scale;
- Stability data for the past six months;
- Validation document on pilot scale;
- Comparative dissolution test.
Upon receiving the application, BPOM will conduct an accelerated review of the application and, if everything is in order, issue a pre-registration approval within six hours. The actual product registration approval itself will depend on the type of drug being registered and could take up to 20 business days for a new drug and five business days for a generic drug.
Conditionality of Registration
It is important to note that the drug registration approval issued by BPOM using the EUA platform is conditional and BPOM reserves the right to revisit the drug registration approval based on further findings on the efficacy, safety and quality of the drug. This means that despite the significantly faster process using the EUA platform, BPOM will still deploy rigorous supervision of drug products.
Other Efforts
In addition to the implementation of the EUA platform, BPOM has announced that it will shorten the importation process for raw materials for drugs to treat Covid-19, from one business day to only two hours. BPOM also plans to employ a fast-track procedure for the certification of manufacturing facilities producing drugs to treat Covid-19, cutting the Good Manufacturing Practice ("GMP") certification process from 10 to five business days.
Further Guidelines
We understand that further regulatory guidelines on the EUA platform and other fast-track procedures are being finalized and will be made public in the near future. A more detailed update to this publication will follow. (April 21, 2020)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
