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.
Last weeks round-up; 9 – 13 March 2020
EMA UPDATE: GUIDANCE ON THE PILOT FOR SIMULTANEOUS NATIONAL SCIENTIFIC ADVICE
EMA has issued an update to the guidance for applicants for the pilot simultaneous national scientific advice (SNSA) process, which is now live. The changes do not look to be anything more than formatting edits (please correct us if we are wrong). So perhaps they are trying to increase the uptake. The process itself is well described in the document which can be found under this link https://lnkd.in/d76bDmG
EMA NEWS: VIRTUAL EMA MEETINGS UNTIL END OF APRIL 2020
In order to limit international travel and the number of visitors going to the offices, and to reduce the risk of an infection with the novel coronavirus for delegates, visitors and staff, EMA has advised that all meetings of EMA committees and working parties will be held virtually until the end of April 2020. In addition, stakeholder events hosted by EMA which were planned to take place at the Agency’s premises in Amsterdam in March and April will either be held virtually or postponed until later in the year. Participants of these meetings will be informed directly about this decision. EMA’s plans are being continually reviewed. The dedicated webpage on COVID-19 is updated as the situation develops. https://lnkd.in/dx4cjB3
