The EMA has released several updates to its pre-authorisation and post-authorisation procedural advice for users of the centralised procedure. Some of the updates include:
The EMA now aims to respond to queries within 10 days instead of 5. Other changes as can be seen in the tracked documents linked here: https://lnkd.in/dpW7TF7
The International Council for Harmonisation (ICH) Management Committee and Assembly has indicated that it intends to collaborate more closely with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and that new topics and reflection papers are currently under development.
ICH Management Committee has proposed that the PIC/S would be involved in ICH guideline work relevant to regulatory assessor [MG1] and inspector disciplines, during the public consultation following Step 2b. Additionally as an ICH Observer, the PIC/S may also request to be part of Plenary Working Parties which would allow its involvement prior to Step 1.
A revised draft reflection paper on model-informed drug development and an update on a draft reflection paper on patient-focused drug development are also in the pipeline. The Biotechnology Innovation Organization has also proposed to develop a reflection paper on gene therapy harmonization. https://bit.ly/RealCMC-3eagyQe
Pharmeuropa has released new supporting information on the new draft Ph. Eur. Chapter 2.4.35 ‘Extractable elements in plastic materials for pharmaceutical use’, which is open for consultation until the end of June 2020. The document proposes that the long‑established individual tests for specific elements are maintained in the Ph. Eur. general chapters on plastic materials, since the quality of plastic materials influences that of the containers manufactured from them.
In future, cross‑reference to this new general chapter will also be made in each existing Ph. Eur. text on plastic materials. The supporting information also indicates that all the existing Ph. Eur. general chapters on plastic materials should be revised to delete the heavy metals test and to perform the tests on target elements according to the new general chapter. https://bit.ly/RealCMC-3bUORJM
“Field Safety Notices (FSNs) are a key part of the medical device vigilance system. Manufacturers are required to inform users about corrective actions involving their device as soon as possible using a Field Safety Notice (FSN). Published on the 20th May by the MHRA to advise manufacturers on how to write clear FSNs to maximise response rates the guidance provides supplementary information to MEDDEV 2.12/1 rev 8 (how to write and distribute effective FSNs) and covers such topics as good traceability, content, effective targeting of FSNs and Field Safety Corrective Action (FSCA) strategy. Manufacturers are advised to read the document via the following link: https://bit.ly/36hrYiH.
We’re proud to have our Real expert, Dorothée Fouchier, attending the virtual 2nd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies, next week alongside our industry peers to discuss the challenges, opportunities and political implications of advanced therapies. If you’re also attending, get in touch! To arrange a meeting visit: https://lnkd.in/dc_SDsr
The European Medicines Agency (EMA) has reduced the fee for on-site GMP inspections by 100%. This fee reduction is only applicable in cases where the GMP compliance of a manufacturing site with restricted access due to the COVID-19 pandemic, could not be confirmed via a distant assessment and an on-site inspection is, therefore, required. Fees for Plasma Master Files inspections will also be similarly reduced.
The EMA has also advised that during this initiative, remuneration to national competent authorities (NCA) will not be reduced, if the NCA provides a comprehensive inspection report for the distant assessment and a subsequent independent report for the on-site inspection. Further information is available here: https://bit.ly/RealCMC-2XbhKMr
The scope of EMAs ITF covers regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products. The objective of the interactions with the ITF is to facilitate informal exchange of information and guidance during the product development process. Interactions take the form of informal brainstorming discussions are led by experts from the Agency network, working parties and committees. These meetings are free of charge and 1.5 hours long. ITF has just issued a new briefing meeting request form in order to standardise company initial dialogue. The form can be found here: https://lnkd.in/dTK2axt
The MHRA inspectorate posted ‘How to manage temporary GDP process changes and risks through the COVID-19 pandemic’ on their blog on the 13th May to advise companies on how to manage changes to GDP processes to address exceptional circumstances that have arisen due to Covid-19. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles. Changes may be documented either as single reports or an over-arching one specific to COVID-19. The post has a link to GDP flexibilities introduced by the MHRA to assist with distribution of medicines during COVID-19 pandemic documented in ‘Guidance Exceptional GDP flexibilities for medicines during COVID-19’. The GDP flexibilities introduced cover Supply Chain, Transportation, RP, Facilities & Equipment and Reporting.
Companies applying these flexibilities need to report to Covid19.GMDP@ mhra.gov.uk as outlined in the guidance, however you only need to report once for each flexibility and reports don’t require approval to implement. The post can be accessed via this link: https://bit.ly/2LIjR5g
The 505(b)(2) route to marketing authorisation in the United States has become very popular. Companies owning a product registered (or eligible to be registered) via this pathway might also wish to submit their product in Europe. Real Regulatory can help companies navigate the significant complexities involved in choosing an appropriate legal basis for submission, setting regulatory strategy and dealing with scientific advice and marketing authorisation procedures.
Read the linked article for an overview of the intricacies and the ways in which we can assist. https://lnkd.in/dzjU_Jj
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a new version of its ‘Application for new Manufacturer’s “Specials” Licence (MS) (Human Use).
To access the new version of the application form please see the following link: https://bit.ly/RealCMC-2ThytN4
2020 will see changes to all regulatory landscapes including Clinical Trials, Medical Devices and Chemistry and Manufacturing Controls changes, with the hopes of implementing a robust and effective regulatory network. The focus is on the New Medical Device Directive and the Clinical Trial Regulations which are designed to keep current with technological and medical advances and help ensure safe and effective medicines and medical devices are delivered to patients. For more information, please see the following link: https://lnkd.in/dcf–H6
The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make best use of big data to support innovation and public health, in a report published 20th Jan 2020. Further details and a pdf of the report can be found here; https://lnkd.in/dB2Czi9
In general, the responsibilities for MAHs relate to outsourcing and technical agreements, that require the MAH to perform certain specific tasks (e.g. evaluating the results of product quality reviews, agreeing irradiation cycles with manufacturers, etc.). These responsibilities are spread over the various chapters and annexes of the GMP guide, and are quite numerous. Further specific details can be found under the link below; https://lnkd.in/dGJb34u