Last week’s round-up, 13-17 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


The Art of doing Clinical Regulatory well

17 January 2020

The landscape of clinical regulatory is becoming increasingly challenging to navigate, with over 8000 clinical trial applications in the EEA every year and increasingly diverse requirements to fulfil.

These challenges have pushed clinical trial sponsors into trying to achieve the same objective with the same or reduced financial and human resources. In order to ease this burden, project management and involvement of experienced CRO and regulatory consultants are vital to the smooth and effective running of clinical trial applications, with a focus on forward planning and anticipating issues that may be raised during the assessment process. More information is available in the article linked below.

One of our consultants, Tessa Fiorini Cohen, contributed to this article.

The Essential List of Regulatory Authorities in Asia

15 January 2020

An updated list of websites for ministries of health and regulatory authorities of countries within Asia and Oceania has been published by RAPS.

Regulatory authority listings cover both drugs and medical devices. The list also notes each country’s membership in regional organisations that have a regulatory component:

Pharmeuropa 32.1 just released

15 January 2020

All new and revised Ph.Eur. monographs are published on the Pharmeuropa website for public consultation. This allows users to comment on these draft texts prior to being adopted by the Ph.Eur. Commission, thus, becoming legally binding standards for all medicinal products concerned in all European member states.

Pharmeuropa 32.1 has just been released and contains 22 drafts. Users have until the 31st March 2020 to leave their comments.

Users are encouraged to give feedback on these drafts and to also take note of any changes to general monographs as these may also affect other monographs where reference to the general text is made.

Ph. Eur. Supplement 10.2 available now

14 January 2020

Following the entry into force of the 10th Edition of the European Pharmacopoeia on 1st January 2020, the 10.2 supplement of the Ph.Eur. is now available. The supplement will be applicable as of 1st July 2020 in 38 European countries and it is included in the 2020 subscription of the 10th Edition of the Ph.Eur.

Grand-Duchy of Luxembourg – Creation of National Medicines Agency

13 January 2020

Luxembourg has set in motion the process to create a national medicines agency.

In December, the Council of Government of the Grand-Duchy of Luxembourg approved a draft bill  to create the “Agence luxembourgeoise des médicaments et des produits de santé” (ALMPS).  Once operational, ALMPS will be responsible for pharmaceuticals, medical devices, cosmetics, food supplements and other health products. It will also govern related activities such as production, commercialisation and clinical trials:

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