Last weeks round-up; 27 April 2020 – 1 May 2020

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AMENDING THE DETAILS OF AN EU ORPHAN DRUG DESIGNATION SPONSOR

EMA has issued updated instructions on how to amend the name and/or address details of a Sponsor of an Orphan Drug Designation. This does not require a new legal act, provided that the sponsor remains the same person or legal entity. Sponsors need to use EMA’s IRIS platform to submit post-designation activities. EMA will not be able to process any submissions outside of IRIS. A change in the name and/or address can be requested only after a designation has been granted by the European Commission. Full details of the guidance can be found https://lnkd.in/dDuFNXs

MCDG GUIDANCE ON MDR CLINICAL INVESTIGATIONS AND EVALUATIONS

Guidance is now available to assist stakeholders in implementing the MDR Clinical Investigation and Clinical Evaluation requirements. The Medical Device Coordination Working Group (MDCG) developed the following guidance documents which were published on the website of the European Commission (EC) on the 23rd April:

The documents provide much needed clarification on MDR requirements pertaining to clinical data and demonstration of equivalence. The documents can be accessed via the following link https://bit.ly/35hqlkA.

EC: MITIGATING CLINICAL TRIAL DISRUPTION IN EUROPE

The European Commission (EC) has issued guidance to ensure that clinical trials can continue during the COVID-19 pandemic. The aim is to mitigate the disruption of clinical research without compromising on quality and safety. With more than 200 coronavirus clinical trials now registered in the EudraCT database, the guidance offers recommendations for simple and flexible measures. Key recommendations of the guidance cover, distribution of medicines to patients, remote source data verification, and communications with authorities. For the latter, the guidance clarifies the classification and notification of these actions. The measures will be used exclusively during the coronavirus pandemic, and will be revoked once the current health crisis in the EU/EEA has been surpassed. https://lnkd.in/gRc5XkX

MDR POSTPONED BY ONE YEAR

In response to Covid-19 the European Commission (EC) adopted a proposal on the 3rd April to postpone by one year the application of the Medical Devices Regulation (MDR). The European Parliament adopted the proposal on the 17th April, followed quickly by adoption of the Council on 22 April. The EC has announced that the amending Regulation 2020/561 was published in the Official Journal on the 24th April and has entered into force on its date of publication. This means that the date of application of the MDR will become 26 May 2021 instead of 26 May 2020 and that the Medical Devices Directives will be repealed one year later on the new date of application of the MDR. EC announcement can be viewed via link here https://bit.ly/2xgRpUq.

Last weeks round-up; 23 – 27 March 2020

EMA NEWS: ONGOING CLINICAL TRIALS AND RISK EVALUATION FOR NITROSAMINE IMPURITIES

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.
https://lnkd.in/g8TVSwk

EUROPEAN COMMISSION (EC) – PROPOSE ONE-YEAR POSTPONEMENT OF MDR IMPLEMENTATION

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

EC ISSUES A TARGETED STAKEHOLDERS’ CONSULTATION ON ANNEX 21: IMPORTATION OF MEDICAL PRODUCTS, OF THE EUDRALEX VOLUME 4

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 NEW GUIDANCE: GUIDANCE ON PAEDIATRIC SUBMISSIONS VIA ESUBMISSION GATEWAY AND ESUBMISSION WEB CLIENT

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.

TIME TO FOCUS ON WHAT WE CAN WORK TOGETHER ON

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 UPDATE: FREE FAST TRACK ADVICE FOR COMPANIES WHO ARE DEVELOPING DIAGNOSTICS OR THERAPEUTICS FOR COVID-19

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 UPDATE TO Q&A ON BIOLOGICALS

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’.

Last weeks round-up; 20 – 24 January 2020

NEW REAL REPORT: EUROPEAN REGULATORY LANDSCAPE 2020

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

EMA AND HMA PROPOSES TEN RECOMMENDATION TO UNLOCK THE POTENTIAL OF BIG DATA FOR PUBLIC HEALTH IN THE EU

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

EMA REFLECTION PAPER ON GOOD MANUFACTURING PRACTICE (GMP) AND MARKETING AUTHORISATION HOLDERS (MAHS)

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

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