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South Africa SAHPRA's Med Dev Guidance: Updated Q&A-Guide to Licensing Medical Device Establishments

In South Africa, the licensing of medical device establishments is a vital step to ensure compliance with national health regulations and...

Sharan Murugan

May 242 min read

UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing,...

Sharan Murugan

Feb 13 min read

UK MHRA: Guidance on the Licensing of Biosimilar Products

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the " Licensing of Biosimilar Products " in...

Sharan Murugan

Dec 21, 20242 min read

UK MHRA Guidance: Applying for a Licence to Market a Medicine in the UK

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published updated guidance " Applying for a Licence to Market a...

Sharan Murugan

Dec 15, 20242 min read

UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence

Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...

Sharan Murugan

Sep 28, 20242 min read

Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products

This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...

Sharan Murugan

Apr 22, 20242 min read

UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation

Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...

Sharan Murugan

Apr 22, 20242 min read

UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences

Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...

Sharan Murugan

Mar 25, 20242 min read

UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device

This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...

Sharan Murugan

Mar 20, 20242 min read

UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine

Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...

Sharan Murugan

Mar 2, 20242 min read

South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments

Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...

Sharan Murugan

Nov 19, 20231 min read

UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK

Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...

Sharan Murugan

Oct 21, 20231 min read

Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity

Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...

Sharan Murugan

Jul 12, 20231 min read

MHRA Guidance: Licensing of Biosimilar Products

Recently (08-November-2022) the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of...

Sharan Murugan

Nov 12, 20221 min read

UK MHRA Guidance: How to get a Parallel Import Licence in UK

Earlier today Today (13 October 2022) Medicines and Healthcare products Regulatory Agency (MHRA) updated its Guidance on Medicines:...

Sharan Murugan

Oct 13, 20221 min read

Philippines FDA: Guidelines on the Unified Licensing Requirements

Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...

Sharan Murugan

Oct 9, 20222 min read

Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices

On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal...

Sharan Murugan

Sep 17, 20221 min read

UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)

Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence" The guidance in general details...

Sharan Murugan

Aug 17, 20221 min read

Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT

Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...

Sharan Murugan

Jun 16, 20221 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...

Sharan Murugan

Oct 13, 20211 min read