Last weeks’ round -up;
21 December -08 January 2021
MHRA advice for prevention of fraudulent representation
The MHRA Inspectorate has released a blogpost on the qualification and re-qualification of suppliers and customers, which are one of the highest risk areas of good distribution practice (GDP). The article focusses on the online resources that suppliers and customers make available and advises stakeholders to be mindful when publishing company information online, in order to avoid attempts of false representation by fraudsters. Vigilance and diligence are required when conducting bona fide checks of customers and suppliers to maintain the integrity of the legal supply chain of medicines and preventing falsified medicines from entering the supply chain.
Updated Ph. Eur. General Chapter 2.9.2 Disintegration of Suppositories and Pessaries
A draft revised Ph. Eur. General Chapter 2.9.2 Disintegration of Suppositories and Pessaries has been published in Pharmeuropa 33.1. The document is available with tracked changes and is open for consultation until 31st March 2021.
MHRA: UK Innovative licensing and Access Pathway (ILAP) for Medicines
In keeping with the wish to maintain its position as a top tier regulatory agency, the MHRA has set out details of its new Innovative Licensing and Access Pathway (ILAP) process. The release details the medicines that are eligible for the new pathway and what is on offer to those medicines which are accepted. It is intended that the process will allow very early entry, based on non-clinical data, as well as catering for products with mid-development ‘global’ dossiers. To maximise the benefits, applicants are encouraged to apply early. Those that are towards the end of their development programme are generally not suitable. The ILAP will be operational from 1 January 2021 and the application form and more details of the process will also be released on this date. Until then the detail release can be accessed here: https://lnkd.in/e5eiyij
UK MHRA issues new guidance on submitting clinical trial safety reports from 1 Jan 2021
UK MHRA has published new guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports / Development Safety Update Reports (DSURs).