5 07, 2023

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners

By |2023-07-05T15:23:42+01:00July 5th, 2023|General News|

New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, the Medicines and Healthcare products Regulatory Agency has announced today. This means that patients will have access to safe and effective medicines that have been approved by trusted regulatory partners in

16 02, 2023

UK retains acceptance of batch testing and EU certification

By |2023-02-16T16:27:10+00:00February 16th, 2023|Featured, General News, General News|

Last year, the UK Department of Health & Social Care issued a statement emphasizing their continued support for the acceptance of batch testing and certification by a Qualified Person (QP) performed in the EU. This statement came after a public consultation seeking opinions on four potential options for a batch testing policy in the UK

14 02, 2023

Q&As on GDP Requirements updated by the EMA

By |2023-02-16T15:54:49+00:00February 14th, 2023|General News, News|

The GMP/GDP Inspectors Working Group has put up and approved a list of frequently asked questions (FAQs) on Good manufacturing practice (GMP) and Good distribution practice (GDP) that the European Medicines Agency (EMA) posts on its website. The list was revised on January 2023. There were three more GDP-related questions added. Maintaining an eye on

3 02, 2023

Sponsor Responsibilities: IMP Shipping & Handling

By |2023-02-03T09:16:07+00:00February 3rd, 2023|General News, News|

In accordance with the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with GCP and GMP," investigational medicinal products (IMPs) cannot be used in a clinical trial in a member state of the European Union until the two-step process has been completed. The

24 01, 2023

What should be taken into consideration when assessing suppliers?

By |2023-01-24T10:59:52+00:00January 24th, 2023|General News|

Wholesalers must ensure that their suppliers are permitted to supply pharmaceuticals. Legal History The following is applicable in accordance with chapter 5.2 of the EU GDP Guidelines (Guidelines on Good Distribution Practice of Medicinal Products for Human Use, 5 November 2013 - 2013/C 343/01): Only individuals who themselves have a wholesale distribution authorization or who

13 01, 2023

Risks in global supply chains : Causes & Solutions

By |2023-01-13T15:21:52+00:00January 13th, 2023|General News|

The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". The document is based on a mandate for a dialogue of different actors in the value chain of medicines from manufacturing, authorities, non-governmental organisations as well as from research. The aim was to gain a better understanding of

3 01, 2023

Accelerating Clinical Trials in EU: 2022-2026 workplan

By |2023-01-04T14:28:54+00:00January 3rd, 2023|General News|

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). ACT EU, launched in January 2022, seeks to transform how clinical trials are initiated, designed and run. The aim is to further develop the EU as a focal

15 08, 2022

Annex 21 in Effect from August 21st 2022

By |2022-08-22T09:07:54+01:00August 15th, 2022|Featured, Industry News, News|

The new Annex 21, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, is now in effect. Are you prepared for it's changes? There are a number of key requirements for a Manufacturing Import Authorisation (MIA) holder when

27 07, 2022

Extension of the comment period by FDA

By |2022-10-18T16:03:00+01:00July 27th, 2022|Featured, General News, Industry News|

FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and

12 10, 2020

MHRA (GxP) Inspections during COVID19

By |2021-10-13T14:21:00+01:00October 12th, 2020|General News|

The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients. This is not just in terms of our regulatory support to bring new technologies and products quickly and safely to market, but also the personnel and

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