Euro Roundup: EDQM says remote inspections could be third pillar for GMP oversight

RoundupsRoundups | 08 July 2021 |  By 

Real-time remote inspections piloted during the COVID-19 pandemic could serve as a third pillar for the supervision of active pharmaceutical ingredient (API) manufacturers, the European Directorate for the Quality of Medicines (EDQM) said.
EDQM began piloting real-time remote inspections, which it refers to by the abbreviation RTEMIS, in 2020 in response to travel restrictions. With the vast majority of the around 40 on-site inspections EDQM performs each year happening in India and China, the organization needed a way to assess compliance with good manufacturing practices (GMPs) despite its inability to visit in person.
The travel restrictions led EDQM to pilot an approach that combined a live video feed with real-time document sharing. EDQM used secure web conferencing applications and a secure document sharing tool. Two web conferencing applications were used, to provide redundancy and allow inspectors to work in parallel, and the secure storage was physically located on its premises. Manufacturers used cellphones, tablet computers and head-mounted devices to capture live video footage. 
So far, EDQM has achieved all the objectives of its real-time remote inspections. The inspections identified minor and major observations that manufacturers are now addressing, leading EDQM to conclude the assessments “led to a satisfactory degree in GMP conformity on the remotely inspected sites.”
There are downsides to the remote approach. EDQM said the inspections require more preparation than on-site visits, for example because of the need for preparatory teleconferences, and the time difference was an issue. EDQM chose Indian companies for the pilot to minimize the time difference but, “Participating inspectors were nevertheless unanimously of the opinion that one or two days of jetlag is easier to deal with than getting up very early for an entire week.”
Despite the downsides, EDQM plans to fully integrate remote inspections into its program, which in the past has relied on in-person visits and documentation-based assessments. EDQM said remote inspections will not replace its existing approaches but could become a third pillar of supervision that is used to confirm or question the GMP-compliance history of companies it has already inspected.
EDQM Report, More
UK opens door to more use of surrogate markers in life sciences strategy document
The UK government has set out its vision for the post-Brexit future of the life sciences industry. The vision includes proposed regulatory changes including an openness to the use of surrogate endpoints to accelerate access to medicines.
Surrogate endpoints are already used to support the approval of drugs that are yet to show efficacy against clinical measures, most controversially in the case of the recent FDA accelerated approval of Biogen’s Alzheimer’s disease product Aduhelm (aducanumab). The life sciences report suggests surrogate endpoints could come to play a bigger role in getting medicines to patients in the UK.
“There is a particular opportunity to support early treatment and prevention through developing innovative regulatory models for the treatment of individuals who are pre disease or have nascent disease, and for diseases (such as dementia) where there are limited or no biomarkers, and a need for surrogate markers or where impact on outcomes will not be seen for many years,” the report states.
The report also covers the UK approach to the regulation of medical devices and in-vitro diagnostics. The delay of the date of application of the Medical Device Regulation meant the UK did not make the European Union legislation part of its law. Freed from the need to follow the EU, the UK plans to use the parts of MDR that “work” but also “aggressively explore and execute improvements that support innovation and drive patient safety.”
Specifically, the UK government wants the Medicines and Healthcare products Regulatory Agency (MHRA) to deliver a leading model for digital health products that, in its view, “are not well regulated anywhere in the world currently.” The government said the broad device and diagnostic regulatory framework, which will be released for consultation later this year, will reflect the fact 95% of affected companies are small to medium-sized enterprises.
Government Report, Press Release
First MDR expert panel opinion challenges notified body, calls for more data
A European Union expert panel has challenged a notified body in the first opinion delivered under a procedure created through the Medical Device Regulation.
The independent experts said the four-month study run to support Ivory Graft’s Ivory Dentin Graft was too short and called out the lack of clinical data on six of the seven indications targeted by the Class III implantable device. As the experts see it, the data are “insufficient” and need to be added to by running a four-month extension to the trial and changing the post-market clinical follow-up plan.
MDR permits the notified body to go against the advice of the expert panel, providing it gives a full justification for its position. The expert opinion also states that “if necessary” the notified body must inform the manufacturer of possible actions such as specific restrictions of the intended purpose and limitations on the duration of the certificate validity.
The opinion of the expert panel on general and plastic surgery and dentistry is expected to be the first of many reports on the clinical evidence in support of medical devices. As part of the rollout of MDR, the EU has set up 10 panels focused on different therapeutic areas that will review evidence flagged by screening experts.
Panel Opinion
MHRA sets out strategic response to ‘substantial and interconnected challenges’
MHRA has published a two-year strategy intended to help it respond to “several substantial and interconnected challenges.”
Typically, MHRA sets out its priorities every five years. However, the extent of the changes that have occurred since the release of MHRA’s plan for 2018 to 2023 have led it to update its strategy partway through the period. MHRA framed the update as a response to four challenges it faces, including the need to create international collaborations and a new, financially sustainable business model.
Upcoming changes will stop MHRA from carrying forward financial reserves. MHRA plans to respond to the changes by introducing a new fee structure, reducing its corporate costs by 15% and cutting its non-pay costs by 10% through contract renegotiation and management. The cuts will come at a time when MHRA will try to overhaul the clinical trial system and create a new medical device framework.
MHRA Report, Press Release
UK and Canada publish joint guideline to improve periodic safety report quality
MHRA and Health Canada have jointly published guidance that calls for clinical trial sponsors to be more transparent about how they review, evaluate and interpret data submitted in periodic safety reports.
The guidance states the detailed safety assessments performed by sponsors are absent from Development Safety Update Reports (DSURs). MHRA and Health Canada want sponsors to use the region-specific information section of the DSUR to include a summary description of the process used to review the worldwide safety data.
Providing more information will facilitate the regulatory review process and cut additional requests of information from regulatory authorities, according to MHRA and Health Canada. MHRA said the guidance builds on existing international standards.
The New Zealand Medicines and Medical Devices Safety Authority agrees with the guidance and will take it into consideration when reviewing national legislation.
Joint Guideline, MHRA Notice


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