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EMA Guidance: EudraVigilance Registration Manual

Jul 19, 20242 min read

EMA Guidance: EudraVigilance Registration Manual

Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...

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EMA Guidance: EudraVigilance Registration Documents

Sharan Murugan

May 17, 20242 min read

EMA Guidance: EudraVigilance Registration Documents

The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...

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Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia

Sharan Murugan

Dec 19, 20231 min read

Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...

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UK MHRA: Guidance on Register Medical Devices to Place on the Market

Sharan Murugan

Dec 3, 20231 min read

UK MHRA: Guidance on Register Medical Devices to Place on the Market

Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...

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MHRA Guidance: Registration & Regulating Medical Devices in UK

Sharan Murugan

Apr 29, 20232 min read

MHRA Guidance: Registration & Regulating Medical Devices in UK

Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...

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Sharan Murugan

Mar 27, 20231 min read

UK MHRA: Guidance on Register Medical Devices to place on the Market

Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...

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Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System

Sharan Murugan

Mar 11, 20231 min read

Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System

Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...

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Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device

Sharan Murugan

Jan 19, 20231 min read

Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device

Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...

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UK MHRA: MD Guidance - Register Medical Devices to Place on the Market

Sharan Murugan

Dec 6, 20221 min read

UK MHRA: MD Guidance - Register Medical Devices to Place on the Market

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

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SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products

Sharan Murugan

Nov 19, 20221 min read

SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products

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

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EMA: Updated EudraVigilance Registration Manual

Sharan Murugan

Aug 25, 20221 min read

EMA: Updated EudraVigilance Registration Manual

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...

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UK updated Guidance: Register Medical Devices to Place on the Market

Sharan Murugan

Jul 31, 20221 min read

UK updated Guidance: Register Medical Devices to Place on the Market

Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...

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Ireland's guidance on New Application & Variations, Registartion Requirements,

Sharan Murugan

Feb 6, 20222 min read

Ireland's guidance on New Application & Variations, Registartion Requirements,

Irelands HPRA released a few guidances in the past week Guide to New Applications and Variations to Manufacturer's Authorisations This...

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Regulating Medical Devices & Place on The Market – UK

Sharan Murugan

Jan 7, 20221 min read

Regulating Medical Devices & Place on The Market – UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This guide...

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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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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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