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Imports & Exports of Therapeutic Goods - Pakistan (DRAP)

Nov 7, 20211 min read

Imports & Exports of Therapeutic Goods - Pakistan (DRAP)

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

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Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA

Sharan Murugan

Nov 7, 20211 min read

Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA

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

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EC MDCG Guidance on Legacy Medical Devices, Repackaging Data

Sharan Murugan

Nov 7, 20211 min read

EC MDCG Guidance on Legacy Medical Devices, Repackaging Data

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

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Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA

Sharan Murugan

Nov 7, 20211 min read

Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA

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...

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Updated Guideline on Registry-Based Studies (EMA)

Sharan Murugan

Nov 7, 20211 min read

Updated Guideline on Registry-Based Studies (EMA)

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

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Finland adopts New Act on Clinical Trials Legislation (FIMEA)

Sharan Murugan

Nov 7, 20211 min read

Finland adopts New Act on Clinical Trials Legislation (FIMEA)

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

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Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals

Sharan Murugan

Oct 19, 20211 min read

Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals

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

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South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application

Sharan Murugan

Oct 19, 20211 min read

South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application

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

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Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices

Sharan Murugan

Oct 12, 20211 min read

Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices

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

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ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities

Sharan Murugan

Oct 12, 20211 min read

ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities

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

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European Commission’s MCGD New Guidance on Classification of Medical Devices

Sharan Murugan

Oct 8, 20211 min read

European Commission’s MCGD New Guidance on Classification of Medical Devices

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

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European Commission (EC) updated guide on Good Lay Summary Practice

Sharan Murugan

Oct 7, 20211 min read

European Commission (EC) updated guide on Good Lay Summary Practice

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

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USFDA’s drafts “Investigator Responsibilities–Safety Reporting for Investigational Drugs & Devices

Sharan Murugan

Oct 3, 20211 min read

USFDA’s drafts “Investigator Responsibilities–Safety Reporting for Investigational Drugs & Devices

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

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USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance

Sharan Murugan

Oct 3, 20211 min read

USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance

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

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FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance

Sharan Murugan

Oct 3, 20211 min read

FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance

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

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MHRA Guidance on need to Review Registration of Medical Devices

Sharan Murugan

Oct 3, 20211 min read

MHRA Guidance on need to Review Registration of Medical Devices

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

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