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 US Food and Drug Administration (FDA) revised its manual of policies and procedures (MAPP) to clarify when certain abbreviated new drug application (ANDA) amendments and supplements should be reviewed by the Office of Generic Drugs’ (OGD) Division of Filing Review (DFR).
Switzerland’s regulatory authority Swissmedic updated guidance on submitting regulatory information in eCTD format to the Swiss Agency for Therapeutic Products.
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.
After successful Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format in the pilot in August 2019, Health Canada begins implementation of Clinical Trials regulatory activities in eCTD format.
The FDA has finalized guidance documents on eCTD submission format for eCTDv4.0 Technical Conformance Guidance and the FDA eCTDv4.0 Module 1 Implementation Package.
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.