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EU MDCG: Revised Device Surveillance Guidance
Medical Device Coordination Group (MDCG) released a second revision to its Surveillance Guidance for Medical Devices, aligning it with EU...
Sharan Murugan
May 31, 20242 min read
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ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
Sharan Murugan
May 31, 20242 min read
33 views
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USFDA Guidance: Platform Technology Designation Program for Drug Development
Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 28, 20242 min read
62 views
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Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...
Sharan Murugan
May 25, 20242 min read
68 views
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EDQM Guidance: Content of the Dossier for Sterile Substances
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a draft guideline titled "Content of the Dossier...
Sharan Murugan
May 25, 20242 min read
48 views
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EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies
The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...
Sharan Murugan
May 25, 20242 min read
22 views
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Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use
The Philippines Food and Drug Administration (FDA) has released a draft (for comments) "Rules and regulations for the authorization and...
Sharan Murugan
May 18, 20241 min read
44 views
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South Africa (SAPHRA): Reliance Guideline
Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the...
Sharan Murugan
May 18, 20242 min read
53 views
0 comments
Switzerland’s Swissmedic: Guidance on Temporary Authorization to Use an Unauthorised Medicinal Product
Swissmedic, the Swiss Agency for Therapeutic Products, has provided guidelines on (15 May 2024) "Temporary Authorization to Use an...
Sharan Murugan
May 18, 20242 min read
29 views
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UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox...
Sharan Murugan
May 18, 20242 min read
13 views
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EMA Guidance: EudraVigilance Registration Documents
The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...
Sharan Murugan
May 18, 20242 min read
21 views
0 comments
Australia TGA: Regulation of Software based Medical Devices
On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...
Sharan Murugan
May 14, 20242 min read
39 views
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Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...
Sharan Murugan
May 14, 20242 min read
48 views
0 comments
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
Recently (09 May, 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released the...
Sharan Murugan
May 11, 20241 min read
15 views
0 comments
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
May 11, 20242 min read
11 views
0 comments
UK MHRA: Guidance on Send and Receive information on Adverse Drug Reactions (ADRs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Send and Receive information on Adverse Drug...
Sharan Murugan
May 11, 20242 min read
101 views
0 comments
Switzerland's SwissMedic: Guidance for requesting Product Certificates (CPP)
On 3rd May 2024 Switzerland's Swissmedic released an updated guidance document "For requesting Product Certificates (CPP)" that guides in...
Sharan Murugan
May 6, 20242 min read
20 views
0 comments
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
Today (06 May 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released two draft guidances...
Sharan Murugan
May 6, 20242 min read
10 views
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UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...
Sharan Murugan
May 6, 20242 min read
16 views
0 comments
Australia TGA: Regulatory requirements for in-house IVDs
Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...
Sharan Murugan
May 1, 20242 min read
20 views
0 comments