Geriatric Information in Human Prescription Drug and Biological Product Labeling Draft Guidance Issued by FDA

The US Food and Drug Administration (FDA) has issued draft guidance on the inclusion of Geriatric Information in Human Prescription Drug and Biological Product Labeling. (more…)

MHRA Released Post-transition guidance on licensing medicines

The UK has left the EU, and the transition period after Brexit comes to an end this year. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.

From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

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US FDA updated MAPP for ANDA consolidation process

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. (more…)

Transfer of Ownership Policy for Generics Updated By FDA

The US Food and Drug Administration (FDA) has made effective a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions. (more…)

EU going to relax GMO regulations for COVID-19 vaccines

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. (more…)

eCTD Supporting Documents in China Available for Public Comments

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: (more…)

FDA revised policies for reviewing ANDA amendments and supplements

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). (more…)

Swissmedic updated eCTD specification and validation criteria to version 1.5

Switzerland’s regulatory authority Swissmedic updated guidance on submitting regulatory information in eCTD format to the Swiss Agency for Therapeutic Products. (more…)

Supplemental Codes for Coronavirus Updated in MedDRA by ICH

The ICH updated the MedDRA (Medical Dictionary for Regulatory Activities) with new supplemental terms and corresponding codes related to COVID-19. (more…)

In Brexit Transition UK MHRA Escape as ‘Leading Authority’ for Drugs

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. (more…)