Regulatory Blog

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May 182 min read

South Africa (SAPHRA): Reliance Guideline

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

Sep 9, 20231 min read

UK MHRA: Guidance on International Recognition Procedure

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure"...

Mar 4, 20231 min read

Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials

Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory...

Nov 27, 20222 min read

Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE

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

Nov 19, 20221 min read

UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk

On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...

Sep 30, 20221 min read

UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension

Earlier today (30 September 2022) to ensure British people have timely access to medicines, the European Commission Decision Reliance...