PRIME is a European Medicines Agency (EMA) initiative to increase assistance for the development of medicines that address an unmet medical need. Through PRIME, the Agency provides early and proactive support to drug developers to maximise the production of reliable data on a medicine’s benefits and risks and to allow accelerated assessment of drug applications. […]
The US Food and Drug Administration (FDA) has made certain changes in the Manual of Policies and Procedures (MAPP) for reviewing the requests to consolidate previously approved generic drug applications.
European Union regulation proposed for relaxing genetically modified organisms (GMOs) requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.
China NMPA has issued drafts before the final release of the supporting documents for the “Measures for the administration of drug registration”, for public consultation:
The ICH updated the MedDRA (Medical Dictionary for Regulatory Activities) with new supplemental terms and corresponding codes related to COVID-19.
UK MHRA will not act as ‘leading authority’ for medicines during the Brexit transaction period as per Article 123 of the draft Withdrawal Agreement. In which UK MHRA will not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States.
FDA to implement all COVID-19 related guidance immediately, without public comment. But will open for public comment after implementation and FDA said it will still solicit comment, review all comments received and revise the guidance documents as appropriate.
The FDA issued new guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic.
Albania entered in to the member state of European Pharmacopoeia as 39th member on 9 February 2020, making the quality standards for medicines published in the European Pharmacopoeia (Ph. Eur.) legally binding throughout the country.
Swissmedic and the Korean regulatory authority extend their cooperation in the area of therapeutic products by recognizing each other for GMP Inspections.