Regulatory Focus™ > News Articles > 2020 > 8 > Euro Roundup: MHRA looks to restart onsite inspections

Posted 13 August 2020 | By Nick Paul Taylor 

Euro Roundup: MHRA looks to restart onsite inspections

2710 The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) aims to resume on-site inspections next month and scale up to a full on-site inspection program in October, according to new guidance.
Onsite good practice (GxP) inspections in the UK halted in March in response to the COVID-19 pandemic. Since then, while other UK businesses have resumed some in-person activities, MHRA has continued to stay away from the facilities and laboratories of the companies it regulates.
Beginning in September, MHRA will resume on-site, risk-based GxP inspections of UK sites. MHRA will continue to use remote inspection approaches alongside in-person activities as the UK eases COVID-19 restrictions and will work to scale up to a full program by October.
The ongoing transmission of SARS-CoV-2 in the UK, which is high enough in parts of the country to necessitate local lockdowns, means MHRA cannot simply return to pre-COVID-19 operations. MHRA typically will provide at least 14 days advance notice of a planned inspection; now, if the agency needs to conduct an inspection at short or no notice for public health reasons, its staff will discuss risk-mitigation measures upon their arrival.
For pre-announced visits, MHRA’s lead inspector will discuss risk assessment and logistics with the targeted organization to ensure compliance with government guidance on managing the outbreak. Barriers to the implementation of the guidance should be discussed during those early talks.
MHRA also wants to use the planning phase to determine what can be done remotely. The agency said it will “work with industry to use technology that enables remote access to information where possible.”
For the inspection itself, MHRA will send the smallest team possible and have them interact with the company’s employees as little as possible. MHRA may use videoconferencing to interview a company’s employees, even if they are all in the same building at the time of the inspection and will use its own laptops to review electronic copies of documents when possible.
MHRA Guidance
MHRA vows to advance AQbD concepts after positive industry feedback
MHRA has set out plans to apply Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines after a consultation identified support for the approach.
The use of AQbD entails building a detailed understanding of analytical methods performance as part of a structured approach to the development of procedures that consistently yield results that meet predefined objectives.
MHRA shared its response to the feedback gathered from a the consultation on AQbD this week, revealing that the process has led it to identify four strategic objectives for AQbD. The objectives set MHRA up to develop guidance, explore the application of AQbD, build its internal capabilities and work with other stakeholders.
To achieve those goals, MHRA has established a work program. MHRA has tasked itself with running more practical case studies to assess the application of analytical target profile models and writing supplementary chapters within the British Pharmacopoeia to provide guidance on the subject.
The work program was informed by feedback gathered through the consultation. MHRA found total support for the role of AQbD in enabling innovation in the small molecule and biologics sectors. The respondents saw opportunities for AQbD to assure the quality of medicines by enabling the use of new analytical methods.
Consultation Outcome
Spain’s AEMPS acts to prevent pandemic-driven shortage of Roche’s Actemra
Spanish physicians who seek to treat COVID-19 patients with Roche’s Actemra should request access to batches of the drug imported specifically for that reason, according a request from the Spanish Agency of Medicines and Medical Devices (AEMPS).
Actemra is one of a clutch IL-6 drugs that researchers identified as potential treatments for COVID-19. Subsequent clinical trials of Actemra and Sanofi’s IL-6 drug Kevzara failed to improve outcomes in COVID-19 patients but AEMPS remains alert to the potential for shortages.
In a notice posted late last week, AEMPS described the clinical data generated to date on Actemra in COVID-19, asked hospitals not to stockpile the drug and told physicians who want to use it to treat coronavirus patients to seek access to supplies imported for that purpose.
AEMPS made the requests to ensure patients with rheumatoid arthritis or cytokine release syndrome following CAR-T administration, the approved indications for Actemra, can access the medicine. The Spanish regulator thinks there is enough Actemra to deal with the current situation.
AEMPS Notice (Spanish)
Finland lifts ban on myxomatosis vaccines after discovery of first infection
Finland has lifted its ban on vaccines against myxomatosis after the discovery of a wild rabbit infected with the virus – the first time the virus had been seen in Finland.
The action by the  Finnish Medicines Agency (Fimea) will lead to the sale of Merck’s live recombinant vector vaccine Nobivac Myxo-RHD PLUS in Finland from later this month, giving people a way to protect rabbits against the virus.
Finland previously banned the sale of the vaccine on the grounds that the disease was not present in the country. European law permits the prohibition of immunological veterinary medicinal products if the disease they target is “largely absent from the territory in question.”
Fimea Notice (Finnish)
EDQM finds paracetamol at center of media contamination probe is safe
The European Directorate for the Quality of Medicines (EDQM) has found paracetamol at the center of a media probe to be safe. EDQM’s investigation showed the paracetamol contained levels of the impurity 4-chloroaniline (PCA) that were well below the acceptable intake.
EDQM did not provide details of the targeted product or the media reports that led to its investigation. However, the details of the investigation map on to Dutch reports about the presence of the potential carcinogen PCA in batches of paracetamol made by a major Chinese supplier.
The Dutch Medicines Evaluation Board downplayed the reports last month, stating the levels of PCA found in the probe were below the threshold for safe use. EDQM reached the same conclusion this week.
“Since the safety of paracetamol is not compromised, as the reported results did not show 4-chloroaniline to be above the internationally agreed acceptable limit, no action has been taken on the concerned certificate, which hence remains valid,” EDQM wrote.
EDQM Notice
Other News:
EMA is seeking feedback on its external communication. The survey, the third of its kind run by the agency, is aimed at patients, consumers, healthcare professionals, academics, media, the pharmaceutical industry and other regulators. The survey is open for around one month. EMA Notice


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