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…)