Last weeks round-up; 27 April 2020 – 1 May 2020
DO YOU WANT UP TO 90% FEE REDUCTIONS AT EMA?
Do you want to access up to 90% fee reductions at EMA?
No existing legal company entity within EU/EEA?
Do you meet the criteria for SME status?
If YES, then Real Regulatory has the solution. Check out the criteria here https://lnkd.in/dKidU2Z, your company can abridge on the existing Real Regulatory SME status to quickly become eligible for the SME incentives. Contact us to action your application now. https://lnkd.in/daQjxxj
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:
- · MDCG 2020-8 PMCF Evaluation Report Template
- · MDCG 2020-7 Guidance on PMCF Plan Template
- · MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
- · MDCG 2020-5 Guidance on Clinical Evaluation-Equivalence.
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:
- Strategise: Review and help you build your project plan in the context of the European requirements.
- Secure: Fee reductions through SME Status, ATMP Classifications, Orphan Designations and Scientific Advice procedures.
- Agency dialogue: To get buy into your project plans, most agencies have switched to virtual meetings for scientific advice.
- Build: Make a start on preparation of the documentation needed to support future CTAs.
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; 21-25 October 2019
NEW REAL REPORT: EMA’S IRIS PLATFORM – ONE YEAR ON
The EMA online IRIS platform for orphan drug designation applications and post-approval activities such as orphan annual reports and orphan transfer applications was launched in 2018. A year after its use became mandatory, Real Regulatory Consultants have written an article that discusses the practicalities, from an industry perspective of using IRIS. The article also discusses the initial set-up and administration steps that should be followed before a sponsor can successfully use IRIS for their orphan submissions. https://lnkd.in/dTmgRqd
RECOMMENDATIONS ON ELIGIBILITY TO PRIME SCHEME
Following its October 2019 meeting, EMA has issued details of its recommendations on applications to the PRIME scheme and updated cumulative statistics on levels of grant vs denials. The latter by far still comprising the largest proportion. Further information can be found at this link. https://lnkd.in/dt25vzN
EMA ISSUES UPDATED Q&A ON MDR
EMA has just issued an updated Q&A on implementation of the medical devices and in-vitro diagnostic medical devices Regulations. Additions are conveniently highlighted in red on the document found on the link below and in particular relate to the effect of the MDR on DDC (drug device combination) products. https://lnkd.in/dizS5Jk
EMA CERTIFICATES THROUGH URGENT AND STANDARD PROCEDURES
As a consequence of the Agency’s move to the permanent building, there will be changes to the timelines for requesting and production of Certificates of Pharmaceutical Products between November 2019 and January 2020. Further specific information can be found in the link below; https://lnkd.in/dgE7Zt4
EMA ENHANCING CONSISTENCY IN WORDING OF THERAPEUTIC INDICATIONS
EMA’s human medicines committee (CHMP) has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines. It outlines key elements for assessors to consider when evaluating the therapeutic indications proposed by the applicant. In this context, the paper also takes into account some of the needs of healthcare decision-makers such as healthcare professionals and health technology assessment (HTA) bodies. A link to the paper is detailed below; https://lnkd.in/davVvvZ
EMA GUIDELINE ON GCP SPECIFIC TO ATMPs
Clinical trials with ATMPs should take into account the specific characteristics of these medicinal products, as well as the potential risks to subjects, investigator’s team and others. While some ATMP specific considerations are explained in this Guideline, it is stressed that these are non-exhaustive and further information should be considered as laid down in the Regulation (EU) No 536/2014.4. https://lnkd.in/eYwABud
EUROPEAN COMMISSION ISSUES A SITE SUITABILITY TEMPLATE FOR CLINICAL TRIAL SPONSORS
A new site suitability template has been published by the EC to help clinical trial sponsors in applications under the EU’s incoming clinical trial regulation (CTR). The new template aids sponsors to explain the suitability of personnel, facilities, equipment and the site to handle the nature and use of the investigational products involved in a clinical trial. The template and other documents relevant to the CTR can be found in the below link. https://lnkd.in/dHJuRqB
