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:

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; 20 – 24 April 2020

MHRA NEWS: EXCEPTIONAL GMP FLEXIBILITIES FOR MEDICINES MANUFACTURERS DURING THE CORONAVIRUS (COVID-19) OUTBREAK

MHRA has updated its guidance on the GMP flexibilities it is allowing on an exceptional basis during the current pandemic. The flexibilities cover two main areas relate to manufacture and importation, and pharmaceutical quality system topics. However, it is stressed that implementation of any described flexibilities is contingent on Qualified Person input to that decision. The guidance also requests companies to speak with MHRA where these flexibilities are not sufficient to overcome current challenges. The full text detailing the specifics can be found here https://lnkd.in/da22tgr

EMA NEWS: 2020/2021 DEADLINES FOR SUBMISSION OF APPLICATIONS FOR OMPD AND CORRESPONDING COMP TIMETABLE

EMA has just updated the deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications, full tabulated details can be found at this link https://lnkd.in/dhRqpEh

EMA PRIVACY STATEMENT – EUROPEAN UNION ELECTRONIC REGISTER OF POST – AUTHORISATION STUDIES

The European Medicines Agency (EMA) has issued a privacy statement regarding the EU PAS Register®. The latter is a publicly available database to provide a register of non-interventional post-authorisation studies (PAS). The Privacy Statement explains the most essential details of the processing of personal data by the EMA in the context of the European Union electronic Register of Post-Authorisation Studies (EU PAS Register), the full statement can be found under the following link; https://lnkd.in/dxK4TAG

Last weeks round-up; 16 – 20 March 2020

REAL REGULATORY IS FULLY OPEN FOR BUSINESS

Real Regulatory has long since had the systems in place to support our clients on a remote basis while our staff too have always had the flexibility to work remotely. At this time, our priority is the safety of our team and the continuation of our high quality services for our customers. In order to protect our fantastic staff and to ensure business continuity, all of our consultants are working from home. We are, as ever, always available if you need support during these times and available to help on an interim or ongoing basis. If you have any queries related to your projects, please don’t hesitate to chat to us: https://lnkd.in/eFeHweG

MHRA CASE STUDY: MHRA’S SPEEDY APPROVAL OF HIGH DOSE FLU VACCINE DEMONSTRATES FLEXIBILITY IN NATIONAL APPLICATIONS

The UKs MHRA has a published a case study detailing how the agency approved a flu vaccine within 7 months rather than the usual 12 month turnaround. Since the 2018 to 2019 flu season, a vaccine specially designed to have optimal efficacy in the elderly has been available for preferential use in the over-65s. More details of the specific case can be found here https://lnkd.in/dkJSuNx The agency is very keen to demonstrate their agility, flexibility and willingness to collaborate with industry. If you need any help with the agency dialogue or need a UK/EU based company entity to become temporary licence holder for your product application. Please contact RRL https://lnkd.in/daQjxxj

MHRA ADVICE: ADVICE FOR MANAGEMENT OF CLINICAL TRIALS IN RELATION TO CORONAVIRUS

MHRA has issued comprehensive advice on managing clinical trials during the period of restrictions imposed as a result of COVID19. Importantly, MHRA has clarified that ‘An increase in protocol deviations in relation to Coronavirus will not constitute a serious breach, therefore there is no need to report this to us (unless of course patients are being put at risk).’ MHRA has specified that prospective protocol waivers remain unacceptable, they would not expect companies to bypass the eligibility process due to difficulties in assessing subjects and carrying out tests. Safety of patients remains a priority and they should not be included into a trial unless they meet the inclusion and exclusion criteria. If the safety of a trial subject is at risk because they cannot complete key evaluations or adhere to critical mitigation steps, then consideration to discontinuing that subject must be discussed, which may also extend to the whole trial in some cases. Urgent Safety Measures may be used to halt, or even temporarily halt a trial, or halt recruitment. A temporary halt, including for logistical reasons such as trial team unavailability, should be submitted as a substantial amendment. http://bit.ly/2Wq7LEg

MHRA INSPECTORATE BLOG: GCP INSPECTIONS: EXPECTATIONS AND THE DOS AND DONT’S OF HOSTING

Inspections are an opportunity to demonstrate your organisations compliance to GCP. Inspectors will always be open and honest, and likewise is expected from the organisations. Inspections and how they are conducted has evolved over the years and has had to, due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology. No longer are trial teams based in one office with a single paper trial master file (TMF). Issues are often encountered during the inspection with TMF access and navigation, document request provision and sometimes simply finding the right person to answer a particular question. This can be frustrating for both parties and may even lead to the extension of the inspection. MHRA has issued a of the dos and don’ts and questions to raise through each phase of the process of conducting a GCP inspection. Full details of the recommendations can be found under this link https://lnkd.in/dX-fast

SAFETY FEATURES FOR MEDICAL PRODUCTS – HUMAN USE

All stakeholders can keep up to date on implementation of technical aspects of Regulation EU 2016/161 via Q&A Document Safety Features for Medicinal Products Human Use updated on the 9th March 2020 to v17 and linked here https://bit.ly/2U6kKIj.

Wholesalers are referred to Section 5 of the Q&A document which addresses VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS, in particular newly added Q&A 5.11 below 5.11. Question: Should wholesalers be connected to the national repositories or can they be connected to the European hub? A wholesaler physically holding products and performing activities related to wholesale outlined in Articles 20-23 Commission Delegated Regulation (EU) 2016/161 (such as the verification of returns or decommissioning for export) should be connected to and perform operations in the national repository where the activities take place.

A connection to the national system is necessary to ensure that the audit trail is accurate and complete. Stakeholders all have an important role to play in implementation of Regulation EU 2016/161 to ensure that public health is safeguarded by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines.