Pharmaceutical Technology - September 2021


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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 47 launch a pilot project to enable a better understand- ing of the root causes of deferred market launches (4). Additionally, Gough noted that a major area for consideration in the strategy is to ensure that the competitiveness and innovation of the European pharmaceutical industry is supported. Ways in which the commission has specified this will be achieved include optimization of the supplemen- tary protection certificates system; revisions of the pharmaceutical legislation; streamlining of approval procedures; boosting competition through generics and biosimilars; and financially and technically sup- porting public-private and public-public partnerships, Gough summarized (4). "The expectation is that we will see a multitude of changes in legislation, towards a clearer and more supportive legal framework for the qualitative and safety aspects of medicines," asserted Marton. "Changes in regulatory procedures should enable accelerated product registration and a calibration of requirements based on the authorities' gathered expe- rience and stakeholders' feedback, and revised clini- cal development and processes will support market competitiveness." The UK's regulator—the Medicines and Healthcare products Regulatory Authority (MHRA)—played a leading role within the EU prior to Brexit, and some changes that are proposed in the strategy are already in place in revised legislation in the United Kingdom, Marton explains. "The end result should be an EU pharmaceutical system that's able to adapt quickly; support innovation; which has upgraded crisis preparedness and response mechanisms; and which promotes Member state authority collabora- tion—to ensure access to high-quality, effective, and safe medicines, ultimately supporting the growth of EU country economies," Marton says. Roadmap to revision As part of its broader strategy, the EC published its roadmap for revising pharmaceutical legislation in March 2021 (5). This roadmap is in its infancy; although the feedback period has now closed, the roadmap is subject to public consultation up until the end of 2021, explains Marton. It is expected that any changes to the EU phar- maceutical legislation will be positive as it should promote regulatory f lexibility in terms of scien- tific and technological developments, will allow for new evidence generation tools to be used, and will make the EU more attractive for investment and marketing of innovative products due to a simplifi- cation of legislative procedures, Gough highlighted in his summary (4). Industry expects that the revised legislation will clarify certain topics that are still under dis- cussion and aspects of regulatory procedures for which industry has traditionally requested advice from regulatory authorities, Marton states. "The aim is to facilitate authority contact especially when a new technology is being developed [that] addresses unmet needs, and to provide enhanced incentives that promote innovation and support increased affordability and access to medicine," she says. "The potentia l to give feedback on drafted documents and engage with authorities in the early stages of legislation development is an opportunity, providing a chance for stakeholders to inf luence the process and ensure that industry expectations can be met." EU–UK relations "On 4 July 2021, the UK MHRA published its own 2021–2023 Delivery Plan," reveals Gough. "Whilst this plan is a lot less detailed than the EU strategy

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