The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic. The guidance can be found here.
The guidance covers the following topics:
- Issues related to marketing authorizations, marketing authorizations procedures
- Manufacturing, importation of finished products and active pharmaceutical ingredients and GMP and GDP issues
- Quality Variations
- Pharmacovigilance including adverse reactions reporting
- Product Information and Labeling
Of particular note, the validity of GMP certificates and time-limited manufacturing and import authorizations, as well as the validity of GDP certificates and time-limited wholesale authorizations, will be extended until the end of 2021. If needed, inspections will be carried out remotely to support such extensions, with on-site inspections carried out as soon as feasible. Inspections, including distant assessments, may be launched and appropriate regulatory actions will be triggered in case of non-compliance. Pre-approval or routine on-site inspections will resume as soon as COVID-19 restrictions are lifted, according to risk-based inspection planning, taking into account the date of the last inspection.
Additionally, the Q&A allows for the QP to accept remote audits of the API supplier when on-site audits are not possible. QPs are also allowed to perform remote batch certification if they have access to all the information necessary to allow them to certify the batch.
This Q&A only applies to medicinal products for human use. The EMA stated that a Q&A document on regulatory expectations for veterinary medicines will be published soon.
