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…)

Implementation of Clinical Trials Regulatory Activities in eCTD Format Begins by Health Canada

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. (more…)

Albania Enters as Member State in European Pharmacopoeia

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. (more…)

Swissmedic and MFDS-Korea sign an agreement on Mutual Recognition for GMP Inspections

Swissmedic and the Korean regulatory authority extend their cooperation in the area of therapeutic products by recognizing each other for GMP Inspections. (more…)

EU Medical Agencies Defines Key principles for the use of electronic product information (ePI)

The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission (EC) have published Key principles outlining a harmonised approach to develop and use of ePI – electronic product information. (more…)

Guidelines for The Pre-Accession Procedure to Join PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has introduced new guideline to The Pre-Accession Procedure to Join PIC/S for competent authorities who interested to join the inspection program. (more…)