Ongoing clinical trials – consultation until 24 April
The EMA has published a “points to consider” document on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials for comment. https://lnkd.in/g9PYa_e
Risk evaluation on Nitrosamines step 1 – extended to 1 October 2020
The European medicines regulatory network has agreed to extend the deadline to complete step 1 risk evaluation of all human medicines containing chemically synthesized active substances for the presence of Nitrosamines to 1 October 2020. This decision follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic.
The EC has announced that because of COVID-19 crisis, work is ongoing on a proposal to postpone the date of application of the MDR for one year to May 2021. The EC are working to submit this proposal in early April and have called on Parliament and Council to adopt it quickly as the deadline for entry into force is the end of May 2020.
The proposed postponement if adopted will provide much relief to the medical device sector amidst this ongoing crisis. The announcement from the Commission can be viewed here https://lnkd.in/dTw3NDR
In addition to the guidance given in the main chapters and annexes of the EU GMP it has become necessary to publish a specific guideline clarifying the application of the principles of GMP in the activity of importation of medicinal products under Annex 21. This Annex sets out the good practice applicable to a manufacturing and importation authorisation (MIA) holders, who import medicinal products (human and veterinary) through the EU/EEA borders. The comments received will be taken into account by the European Commission in the finalisation of the Guideline. It will run from 20th March 2020 through to and including 20th June 2020. All stakeholders are invited to respond to the draft guidance here https://lnkd.in/dgyWg3E and to use the template for responses here https://lnkd.in/drgVsqK. The format and email for responses are also detailed on the site.
EMA has issued a short practical guidance on making submissions for paediatric investigation plans and waivers via the eSubmission Gateway and the eSubmission web client platforms. The guidance states that a letter of intent for PIPs and PIP waivers is no longer required, it includes a full listing of documents required by submission type and a very good tabulation on naming conventions for each of the files comprising the submission.
The new guidance can be found here https://lnkd.in/giT5HjD and there are further links therein to other specific supportive documents.
Focusing on what we can work together on:
We have the team and skillsets to help you with these activities. We are all ready and available to do so. Please see our website for further details of our services, www.realregulatory.com
NICE Scientific Advice will provide free fast track advice for companies who are developing novel diagnostics or therapeutics for COVID-19.
The fast track service will help companies optimise their approach to generating essential levels of evidence required for health technology assessment. Depending on the demand for the free advice service, NICE may need to prioritise requests.
All scientific advice services will continue to run as normal, with meetings taking place virtually for the foreseeable future. Developers are invited to get in touch via our online form with enquiries about any of their services. https://lnkd.in/d48KfmC
CMDh has just updated their Q&A on Biologicals, full details can be found under this link https://lnkd.in/dAjYHw5
Apart from generally updating reference legislation, in section 3 detailing special requirements for biological products an important bullet point on the legal basis has changed.
The legal basis for MAs as bibliographic applications according to Article 10a of Directive 2001/83/EC are now ‘strongly discouraged’. It is also further stressed that ‘It is highly recommended to ask the RMS for scientific and regulatory advice on the most appropriate legal basis’.
With over 8000 clinical applications every year, the landscape of clinical regulatory is becoming increasingly challenging to navigate. These additional challenges have pushed Sponsors into trying to achieve the same objective with the same or reduced financial and human resources. For this to be possible, 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. For more information, please see the following link: https://lnkd.in/dQKjmDW
The HPRA have published an update to their Guide to Labels and Leaflets of Human Medicines at the beginning of January 2020. Amendments have been made to the information on leaflets and package labelling which does not require formal assessment and do not need to be notified until the next regulatory opportunity. More specifically, the HPRA does not require a formal notification when administrative information from an EU member state or the UK in the blue box is either added, deleted or changed, as long as no other changes are made, and it does not impact on the livery of font size of the packaging. The bulk of the update relates to multilingual packaging requirements.
The HPRA encourages the use of multilingual packaging, in the case of supply shortages on the Irish market, provided the readability is not compromised, following the principles of the CMDh Best Practice Guide on Multilingual packaging. New considerations are given to packaging which includes third country information (such as UK details), joint names and small immediate packaging unit requirements. For further information, please see the following link: http://bit.ly/2R73KAa