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Posted 01 October 2015 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has released guidance on how good laboratory practice (GLP) facilities can adopt risk-based quality assurance. MHRA sees risk-based methods as being more proactive and efficient than alternative approaches.
GLP facilities in the UK are free to adopt risk-based quality assurance programs. The new guidance in no way changes this or anything else. Instead, the document is intended to complement the OECD Principles of GLP and UK GLP Monitoring Authority guidance, notably by clarifying what MHRA looks for in a risk-based quality assurance system. By following its advice on the questions to ask during risk assessments and establishing continual improvement, MHRA thinks sites can become better.
“A risk-based quality assurance inspection program should add value to a GLP quality system, by targeting resources to areas that present the greatest potential for non-compliance,” MHRA wrote in the guidance. “It should also enhance the identification and prevention of poor compliance by ensuring processes are in place that assess risk and consider the impact of errors on studies, systems or the facility as a whole.”
The implementation of a risk assessment lifecycle is the centerpiece of MHRA’s advice. This process begins with a risk assessment, during which sites should consider threats to GLP compliance, what might go wrong, the likelihood of these events occurring and what would happen if they were to do so. The resulting risk assessment will identify the biggest threats to GLP compliance at the site. Staff can then focus their time and resources on these critical elements of the operation.
MHRA recommends GLP sites then establish an inspection regime. The findings from inspections, plus quality metrics and information from external sources, are fed back into the risk assessment process. In this way, the quality assurance priorities and inspection program are continually revised in response to changes to the risk profile.
The Swiss Agency for Therapeutic Products (Swissmedic) has taken part in raids on six properties in relation to the production of human cell therapies. Police have taken three people into custody on the suspicion having illegally manufactured and distributed medicines in Switzerland and Italy.
Swissmedic is working with the police, the Zurich public prosecutor and Italian authorities on the ongoing investigation, which is centered on the use of human cell extracts as medicines. Full details of why the three people in custody are suspected of violating the Therapeutic Products Act are yet to emerge, but Swissmedic has provided an overview of why it became interested in the individuals and background information on the law.
The regulator described the products in question as containing preparations made from human cell constituents. In background information, Swissmedic added that medicines that are produced from human or animal tissue but contain no living cells are covered by the Therapeutic Products Act. This brings it under the jurisdiction of Swissmedic. If a product contains living cells, it is covered by the Transplantation Act, although processing steps are subject to the Therapeutic Products Act, too.
Having searched six locations in the German-speaking part of Switzerland. Swissmedic is continuing to work with its partners on the case. The people in custody are presumed innocent until proven guilty.
The National Health Service (NHS) in England has published guidance to help physicians and budget holders manage the adoption of biosimilars. NHS England has written the document to give anyone involved with the purchasing, prescribing and monitoring of biologics a primer on biosimilars.
As a new class of products, biosimilars are subject to certain issues that may be unclear to people in the healthcare system. The NHS England document is designed to eliminate these knowledge gaps, notably by clarifying that physicians retain control over whether a biosimilar or originator product is prescribed. To avoid pharmacy-level substitution, NHS England is encouraging physicians to use the brand name when they want to prescribe an originator. Generic names are typically used in the UK.
Members of the National Institutes of Health and Care Excellence and MHRA have worked on the document with NHS England and representatives of the Association of the British Pharmaceutical Industry (ABPI), the UK BioIndustry Association, the British Generic Manufacturers Association and the Royal Pharmaceutical Society. The result is a document that has the broad support of both the innovative and generic drug industries.
“ABPI and its members believe that what we need now is a process for translating the successful experience of biosimilar development and regulation into the clinical pathway. This NHS publication is a critical step in developing the understanding and awareness to do this,” Virginia Acha, executive director, research, medical and innovation at ABPI, said.
NHS Guide, ABPI Statement
The Finnish Medicines Agency (Fimea) has posted guidelines on the advertising of medicines that are subject to additional monitoring. Marketing materials for such medicines must display an inverted black triangle, the specifications of which are the focus of the Finnish guidance document.
Fimea wrote the document in response to adverts in medical journals and on websites that failed to comply with its standards. The size and other details of the inverted triangle are set in regulations from the European Commission, yet, despite this, Fimea has caught companies incorrectly displaying the warning in medical journals and on websites. Specific examples include the use of triangles that are different colors, smaller than the specified size or incorporated into product logos.
The guidelines make it clear that such changes are forbidden. Inverted warning triangles must be black, at least 5mm long on each side and accompanied by an easy-to-read line of explanatory text. Both the triangle and the text must be kept separate from other elements of the marketing materials and scaled up so as to be in proportion with the rest of the advert. Fimea has also clarified how firms can translate these requirements to electronic materials.
Press Release, Fimea Guidelines
The Committee for Medicinal Products for Human Use (CHMP) has recommended 19 medicines for marketing authorization at its busiest meeting of 2015. CHMP gave its backing to Boehringer Ingelheim’s Pradaxa antidote Praxbind,Novartis’ heart failure drug Entresto and Amgen’s multiple myeloma treatment Kyprolis. Press Release
MHRA has alerted users about a change to the procedure for validating variations to copycat marketing authorizations (MA). Holders of copycat MAs can no longer use the unforeseen Type IB-z category. Instead, the relevant category for the change must be used. Parent MA holders must tell holders of copycat MAs when they make a change and inform them of the category. MHRA Notice
EMA has extended the deadline for expressions of interest from civil society members in joining two of its committees. People can now register their interest in joining the Pharmacovigilance Risk Assessment Committee and the Committee for Advanced Therapies until 18 October. EMA Statement
A court in the UK has given a man a suspended five-month prison sentence for supplying a children’s cough syrup that was known to be defective and due to be destroyed. MHRAseized the products from retailers. The man also acquired other defective controlled drugs and failed to have them destroyed. Press Release
Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup
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