Regulatory Blog

Swissmedic, the Swiss Agency for Therapeutic Products, has published comprehensive guidance "Renewal and Discontinuation of Authorization...

The US Food and Drug Administration (FDA) released the final guidance yesterday (14 June 2024) titled "Clinical Pharmacology...

The European Medicines Agency (EMA) has proposed amendments to the European Commission's "Guidelines on Variations Categories and...

Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...

The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...

The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...

The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...

On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...

Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...

Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a draft guideline titled "Content of the Dossier...

The Philippines Food and Drug Administration (FDA) has released a draft (for comments) "Rules and regulations for the authorization and...

Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the...

Swissmedic, the Swiss Agency for Therapeutic Products, has provided guidelines on (15 May 2024) "Temporary Authorization to Use an...

The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...

Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Send and Receive information on Adverse Drug...

On 3rd May 2024 Switzerland's Swissmedic released an updated guidance document "For requesting Product Certificates (CPP)" that guides in...