- In response to recent legal developments relating to emergency use authorizations (“EUA”) for the use of drugs during public health emergencies, the Head of the National Agency for Drug and Food Control (“BPOM”) has issued Decree No. HK.02.01.1.2.06.21.234 of 2021 (”Decree 2021”), which has now amended the technical instructions for the issuance of EUA, as originally addressed under Decree of the Head of the BPOM No. HK.02.02.1.2.11.20.1126 of 2020.
- In addition to setting out the documents required for EUA issuance applications, Decree 2021 now also requires pharmaceutical industries to submit copies of the relevant cooperation agreements, which must at least contain details on any division of authorities and responsibilities that relate to product safety, efficacy and quality, both prior to and after the issuance of EUA.
- In terms of the types of data required to be set out under any mandatory safety, efficacy and quality documents that accompany EUA issuance applications, specifically in relation to vaccines, Decree 2021 also now requires the following data to be provided: 1) In terms of safety and efficacy data (specifically non-clinical data): Toxicity testing carried out on at least two animal species, immunogenicity testing carried out on the most appropriate animal and, if said drugs are for COVID-19 treatment, testing on animals must be carried out in order to predict the effects of said drugs upon human life and any risks relating to enhanced respiratory disease; and 2) In terms of quality data: three bets of pilot-scale validation process reports must be provided for new drugs and biological products and one bets must be provided for generic drugs.
- Decree 2021 has now added a new requirement for the distribution of imported vaccines, specifically lot release approvals, as granted by the BPOM.
- Decree 2021 now authorizes the BPOM to perform sampling and testing of circulated vaccines in order to ensure their safety and quality if, among other potential outcomes, post-immunization effects occur in relation to the use of drugs (including vaccines). Pharmaceutical industries may also be required to provide samples, materials and kits and/or referred materials (baku pembanding). If sampling and testing processes reveal that drugs have failed to meet the relevant safety, efficacy, quality and labeling requirements and/or standards, then drugs may be withdrawn and destroyed.
- Decree 2021 has been in force since 3 June 2021.
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