Regulatory Blog

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, " Renewal, Discontinuation, and Status Change of...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance" Submission of Periodic Safety Update Reports...

Clinical trials are a cornerstone of medical advancement, requiring meticulous planning and adherence to regulatory guidelines. In India,...

The European Medicines Agency (EMA) has released an updated procedural guidance document on the " Appointment of CHMP, CAT, and PRAC...

The Medicines and Healthcare products Regulatory Agency (MHRA) has established comprehensive guidelines detailing the " Format and...

The European Medicines Agency (EMA) has released an addendum to its Guideline on the " Clinical Development of Vaccines to address the...

The European Medicines Agency (EMA) has released a concept paper  proposing the development of a guideline for the assessment and...

The Food and Drug Administration (FDA) of the Philippines has recently published draft guidelines to streamline the registration process...

The South African Health Products Regulatory Authority (SAHPRA) has updated its " Fee Schedule and Explanatory Notes "  to renew human...

The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on " Clinical trials for medicines: manage...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that...

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently initiated a public consultation on draft guidance for "...

Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of human research subjects. To enhance...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry on the process for the...

Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...

Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...

The European Medicines Agency (EMA) provided detailed revised guidance "Procedural Advice for Orphan Medicinal Product Designation " for...

On 21st January 2025, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research issued final guidance "...