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…)

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…)

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…)

COVID-19 Related Guidance Immediately Implementing Without Public Comment by FDA

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. (more…)

FDA Released Clinical Trials Guidance for Medical Products Impacted by COVID-19

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. (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…)