Regulatory Blog

A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...

Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “M11...

Yesterday (26-December-2022) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Requirements for...

Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...

Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...

Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...

Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic...

Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...

Earlier today UK Medicines and Healthcare products Regulatory Agency released an updated guidance on "Register medical devices to place...

Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...

Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...

Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...

On 22nd November, 2022 Singapore's Health Sciences Authority released the final Regulatory Guidelines for Laboratory Developed Tests...

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File...

Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...

On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...

Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...

Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...

Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...