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

13 03, 2023

MIAS Pharma TO ATTEND BIO-EUROPE SPRING® 2023

By |2024-01-29T15:47:25+00:00March 13th, 2023|Events, General News|

MIAS Pharma will be attending 17th annual BIO-Europe Spring taking place March 20–22, 2023 in Basel, Switzerland. After being delivered digitally over the last two years, the event is expected to bring together over 2,800 executives from biotech, pharma and finance companies to engage in 15,000+ one-to-one meetings. BIO-Europe Spring is the place to meet

16 02, 2023

UK retains acceptance of batch testing and EU certification

By |2024-01-02T10:39:42+00:00February 16th, 2023|Featured, 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 |2024-01-23T15:49:36+00:00February 14th, 2023|General 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 |2024-01-23T15:53:01+00:00February 3rd, 2023|General 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

20 01, 2023

EMA starts a pilot study to analyze clinical trial raw data

By |2024-02-12T11:38:18+00:00January 20th, 2023|General News|

The European Medicines Agency (EMA) has launched a pilot project to assess the benefits of analyzing raw data from clinical trials by regulatory authorities when evaluating marketing authorization applications (MAAs) for new medicines, as well as post-authorization applications. Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible

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

4 01, 2023

Amended Labeling Requirements for IMPs

By |2024-01-02T10:40:12+00:00January 4th, 2023|General News|

Following a 1-month feedback period on the draft published in June last year the European Commission (EC) finally adopted on 6 September 2022 the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) as regards labelling requirements for IMPs. The Regulation will enter into force on the twentieth day following its publication in the

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