Euro Roundup: EMA consults on planned update to computerized systems annex of GMP guide
The European Medicines Agency (EMA) is seeking feedback on the planned revision of the good manufacturing practice (GMP) annex on computerized systems. The agency wants to revise the existing text, which dates to 2011, because it “does not give sufficient guidance within a number of areas.”Annex 11 applies to all sets of software and hardware components, which EMA defines as computerized systems that are used as part of GMP-regulated activities. The annex is used in the European Economic area and by participating authorities in the Pharmaceutical Inspection Co-operation Scheme (PIC/S). An EMA working group and PIC/S have agreed on a concept paper that outlines 33 reasons for the revision.
“The current Annex 11 does not give sufficient guidance within a number of areas already covered, and other areas, which are becoming increasingly important to GMP, are not covered at all. The revised text will expand the guidance given in the document and embrace the application of new technologies which have gained momentum since the release of the existing version,” according to the paper.
EMA and PIC/S have identified a need for requirements for “data in motion” and “data at rest” as part of the annex’s focus on data integrity. The partners also plan to add references to the International Council for Harmonisation’s Q9 text, expand the annex’s expectations of providers of cloud services and clarify the term “commercial off-the-shelf products.”
Artificial intelligence and machine learning also are a focus. EMA wants the annex to cover algorithms used in critical GMP applications, if possible, noting that “this is an area where regulatory guidance is highly needed as this is not covered by any existing regulatory guidance in the pharmaceutical industry and as pharma companies are already implementing such algorithms.”
Officials drafted the concept paper before the US Food and Drug Administration (FDA) published draft guidance on Computer Software Assurance for Production and Quality System Software. EMA plans to consider the FDA guidance and its implications with “regards to aspects of potential regulatory relevance for GMP Annex 11.”
EMA is accepting feedback until 16 January. The comments will inform draft guidelines planned for consultation in December 2024. Officials aim to finalize the document in 2026.
Concept Paper
Sanofi secures European approval of Beta variant COVID vaccine as a booster shot
The European Union has approved Sanofi’s COVID-19 vaccine as a booster for adults. Sanofi’s product, VidPrevtyn Beta, is a recombinant protein vaccine based on the Beta variant of SARS-CoV-2 that uses an adjuvant from GSK to strengthen the immune response.
Sanofi and GSK fell well behind the frontrunners in the COVID vaccine race, when lackluster data on their original candidate prompted the partners to rethink the antigen formulation. The refined antigen formulation was designed to achieve an optimal immune response, including in older adults. As variants proliferated, the partners focused on a Beta-specific vaccine.
The authorization, which the European Commission granted shortly after EMA made its recommendation, is based on data from two immunobridging trials.
In one study, VidPrevtyn Beta triggered higher production of antibodies against the SARS-CoV-2 Omicron BA.1 subvariant than the original version of Pfizer/BioNTech’s Comirnaty when given as a booster. Based on the data, EMA’s Committee for Medicinal Products for Human Use concluded VidPrevtyn Beta is expected to be at least as effective as Comirnaty at restoring protection against COVID. The conclusion led to the recommendation for approval of the product as a booster in people previously vaccinated with an mRNA or adenoviral vector COVID vaccine.
EMA Notice
Access Consortium establishes stance on GMP mutual recognition
A consortium featuring regulatory agencies from Switzerland and the United Kingdom has published a statement outlining its position on the reliance and recognition of GMP inspection reports issued by other members.
The Access Consortium, formerly known as ACSS, is a coalition of regulatory agencies that represent Australia, Canada, Singapore, Switzerland and the UK that aims to reduce duplication and increase each agency’s capacity through international cooperation.
“The Consortium members will commit to accept GMP inspection reports issued by Access members for GMP inspections conducted within their territory, in lieu of conducting another GMP inspection,” according to a statement from Access. “The Consortium will maximize the existing GMP Inspection reliance and mutual recognition agreements in place and work closely together to expand their use wherever possible for products undergoing evaluation.”
The regulatory agencies believe that GMP inspection reliance arrangements and formal mutual recognition arrangements “are highly effective tools” that can help “manage increasing complexity in the manufacturing and supply chain of medicines in a timely manner.” The consortium expects the approach to reduce the regulatory burden on stakeholders and facilitate timely access to medicines.
Consortium Statement
MHRA case study shows how horizon scanning identified need for AAV standardization
Horizon scanning enabled the UK Medicines and Healthcare products Regulatory Agency (MHRA) to identify a need to standardize adeno-associated viral (AAV) products to support developers and manufacturers, according to a case study report release by the agency
With the gene therapy pipeline growing, MHRA assessed the analytical and manufacturing barriers facing the field, which relies heavily on AAVs as delivery vectors.
“Without a reference material to benchmark their products to it is difficult to establish the concentration (copies or particles per mL), and the particle empty/full ratio of products. To this end, AAV reference materials are required, that are available and used by all, to further advance the field,” MHRA wrote.
MHRA secured a £3.7 million ($4.4 million) grant from the Regulators’ Pioneer Fund, an initiative from a government department, to support the manufacture and characterization of an AAV reference material. The money supported the production, purification and analysis of a batch of AAV2 material. MHRA trialed freeze-drying the material to remove the need for a low-temperature-controlled supply chain.
Industrial stakeholders, academic laboratories and other external collaborators now are evaluating the AAV2 batch and assessing its fitness for use as a reference material. MHRA hopes the initiative will increase patient confidence in AAV therapies and the safety of the medicines.
Case Study
Other news:
MHRA has approved the bivalent version of Comirnaty that is adapted to the BA.4 and BA.5 subvariants of omicron. The approval of the Pfizer/BioNTech vaccine follows the earlier authorization of a BA.1 form of Comirnaty. Like other regulatory agencies, MHRA used clinical data on the BA.1 vaccine to inform its decision to authorize the updated BA.4/BA.5 booster. MHRA Notice
Medicines for Europe has called for the European Union and national regulators to develop policies to encourage generic and biosimilar medicines use and broaden patient access. Press Release
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