Regulatory Blog

Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines that describe the requirements for commercial imports and...

Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...

The European Commission’s Medical Device Coordination Group (MDCG) released a document detailing how the newly implemented Medical Device...

This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when...

This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support...

The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the...

Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...

This guideline is intended to provide information and guidance to applicants/HCRs on the prescribed requirements and process to be...

On 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and...

The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...

European Commission’s Medical Devices Coordinating Group (MDCG) on 04-October-2021 issued guidance to support manufacturers classify...

The European Commission (EC) on 04-October-2021 has put out recommendations on finest practices for preparation, translation and...

The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting...

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and...

USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...

MHRA agency on 27 September 2021, provided the advice in an update to its guidance on "registering medical devices. MHRA has asked...