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Posted 19 May 2022 | By Nick Paul Taylor 

Euro Roundup: EMA seeks feedback on remote batch certification post-pandemic

2886 The European Medicines Agency (EMA) has proposed allowing qualified persons (QPs) to remotely certify batches routinely even after pandemic-related travel barriers are over.
 
When the pandemic hit, manufacturers operated in business continuity mode and EMA posted guidance on regulatory flexibility to enable companies to minimize the risk of shortages while maintaining high standards of quality, safety and efficacy. EMA recognized that QPs needed to adapt to the pandemic environment and allowed remote batch certification when they were unable to visit the site in person.
 
Now, the GMDP Inspectors Working Group is reviewing these flexibilities and has released  a draft question and answer document on their current thinking.
 
The first answer states: “Remote batch certification/batch confirmation could be allowed if accepted by the national competent authority where the authorized site is located. Some competent authorities may have specific requirements regarding the location of QPs or the implementation of remote batch certification/batch confirmation on a routine basis. Manufacturers and QPs should ensure that they comply with any applicable local requirements.”
 
Another question covers the conditions that should apply when remote QP certification is allowed routinely. The Q&A proposes a risk-based system. QPs need to maintain their knowledge of the products, manufacturing processes and pharmaceutical quality system and be satisfied that the “ongoing reliance on the relevant pharmaceutical quality system is well-founded.” As such, the time QPs spend at a site “should be commensurate with the risks related to the processes at the authorized site.”
 
Operations that make routine use of remote QP certification should describe and control the work in the pharmaceutical quality system and adopt relevant detailed site procedures. Technical agreements with contract QPs should specify the circumstances in which the QP must visit the site. QPs need electronic access to all necessary information when making a batch certification decision and to visit sites in person “where there are specific issues or cases which cannot be satisfactorily clarified or resolved remotely”.
 
Another question addresses the technical requirements for remote access and the signature used for batch certification. The Q&A states remote access carries a higher IT security and data integrity risk than on-site activity and as such certain precautions need to be taken. Recommendations include encrypting hard disks and disabling ports before hardware is sent off-site, configuring the security parameters of virtual private networks used by QPs and adopting two- or multi-factor authorization.
 
 
EMA is accepting feedback on the draft until 13 June.
 
Consultation Document
 
European Pharmacopoeia adopts first ‘horizontal standard’ for monoclonal antibodies
 
The European Pharmacopoeia has adopted a general chapter on using cell-based assays to determine the potency of TNF-alpha antagonists such as Amgen’s Enbrel and Johnson & Johnson’s Remicade. The text is the first of three planned horizontal standards for monoclonal antibodies.
 
The horizontal standard initiative grew out of stakeholder demand for “a set of widely applicable recommendations for analytical testing strategies” covering classes and subclasses of antibodies, according to a statement from the European Directorate for the Quality of Medicines and Healthcare (EDQM
 
The first horizontal standard is intended to “establish well-defined and globally harmonized methodologies, addressing common expectations widely applicable to TNF-alpha antagonist potency determination.” The text describes how to perform “four commonly used cell-based assay procedures and universally applicable parameters/criteria to support system and sample suitability testing.”
 
As part of the process, Pharmacopoeia has revised two existing monographs on the active ingredients in Enbrel and Remicade to create links between their potency sections and the new horizontal standard.
 
The standard has an implementation date of 1 April 2023.
 
EDQM Notice
 
MHRA approves Roche’s Vabysmo through Access Consortium work share
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Roche’s bispecific eye disease drug Vabysmo after working with other members of the Access Consortium to review the submission.
 
MHRA joined Australia, Canada, Singapore and Switzerland in the Access Consortium in October 2020, post-Brexit. Vabysmo, a bispecific antibody for use in patients with age-related macular degeneration or visual impairment due to diabetic macular edema, is the first drug approved by MHRA under the consortium's new drug work-sharing program.
 
Roche is still awaiting approval in the EU. Sajid Javid, the UK health and social care secretary, was quick to try to paint the MHRA approval as a benefit of Brexit.
 
“Now we have left the EU, the UK is free to team up with other world-leading regulators to speed up the approval process for medicines, while maintaining the highest safety standards – and this is a great example of UK patients getting quicker access to cutting-edge treatments,” Javid said.
 
Press Release
 
Greek government steps up pursuit of compensation from Novartis in bribery case
 
The Greek government has set out the next steps in its pursuit of bribery allegations against Novartis, revealing it plans to bring an order to claim compensation and appoint a law firm in the US to defend its rights.
 
Novartis reached a $345 million agreement with the US Department of Justice and the US Securities and Exchange Commission to settle foreign bribery claims relating to countries including Greece in 2020. The settlement related to allegations about bribing employees of state-owned and state-controlled hospitals and clinics in Greece and the false recording of improper payments.
 
While Novartis settled in the US, it still faces a challenge in Greece. The government is framing its pursuit of Novartis as a way it is different from the previous administration.
 
Government Notice (Greek)
 
Swissmedic authorizes Moderna COVID vaccine for children aged 6 to 11 years
 
The Swiss Agency for Therapeutic Products (Swissmedic) has approved Moderna’s application to extend the use of its COVID-19 vaccine Spikevax to children aged six to 11 years.
 
Swissmedic began reviewing the application late last year. The positive decision rests on evidence that the immune response in the population is comparable to that seen in young adults, and that the adverse event profile is acceptable. Swissmedic said fever occurred more frequently in children, but muscle and joint pains were rarer. The authorization covers two half doses of Spikevax given four weeks apart.
 
The approval comes five months after Swissmedic authorized Pfizer and BioNTech’s rival mRNA COVID-19 vaccine Comirnaty for use in children aged five to 11 years.
 
Swissmedic Notice
 
Other news:
 
The European Commission has updated its implementing decision on harmonized standards for quality management systems, sterilization and application of risk management to medical devices. The new text reflects a correction to an ISO standard on quality management systems that did not affect the substance of the standard. Implementing Decision  
 
TUV NORD Polska has been designated as a notified body under the Medical Devices Regulation (MDR). The designation brings the total number of notified bodies currently cleared to certify medical devices under MDR up to 29. TUV NORD Polska is the only MDR-designated body in Poland. NANDO Page

 

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