Review of Legislation
This article was originally published in SRA
South Africa considering draft legislation on medicines
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Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.
The coronavirus could have serious adverse effects on regulatory procedures at both European Medicines Agency and EU member state level. A new business continuity plan describes how procedures will be prioritized if problems arise.
After a tepid performance in the fiscal fourth quarter, Torrent expects its key markets India, US and Brazil to be impacted by the COVID-19 fallout as well as a lack of visibility on regulatory approvals for its manufacturing facilities.