Review of the 9th Middle East Regulatory Conference - Drug ...

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530 p r o c e e d i n g s Ball, Fallows fore registration. The reference biological product must be authorized in the EU on the basis of a complete dossier, used as reference throughout the full development (quality, safety, and efficacy) of the biosimilar, to allow generation of coherent data and conclusions, at the time of launch of the biosimilar. A biosimilar is not a generic because biologicals are more complex than chemical products and therefore more difficult to fully characterize. Subtle differences between biosimilars may not be apparent with today’s analytical methods. These subtle differences may be due to differences in raw materials or manufacturing processes and may relate to structural differences in the active substance or impurity profiles. These have an important impact on safety or efficacy and hence the need for nonclinical and clinical studies to be conducted. Dr Uguen’s takehome message was that biosimilar product development and dossiers are complex and as a consequence, comparative trials must be conducted to demonstrate similarity to the reference biological medicinal product. h a r m o n i Z at i o n o f d o c u m e n tat i o n f o r m a r K e t a c c e s s Moving on from MERC 8, this session presented an opportunity for discussion and feedback on how the Middle East regulatory authorities had progressed toward a harmonized ICHCTD structure and an opportunity for industry to present its perspective, with significant debate and collaboration. Ctd/E-Ctd: an Eu rEguLatory authority PErsPECtivE dr Christa wirthumer-hoche, agEs Pharmmed, vienna, austria, highlighted that the Common Technical Document (CTD) provides a common format and not necessarily common content and explained that until now CTD has been mandatory in the EU and eCTD is recommended and not yet mandatory, except in the case of esubmission. She spoke about an ongoing process to improve and develop a new major version of the eCTD including an eapplication form, product information management, and the perspective of the European agencies to have a European submission and tracking system via twoway electronic communication with the industry. sFda: ChaLLEngEs and LEssons LEarnEd hassaan al wohaibi, regulatory affairs manager at the sFda, saudi arabia, gave an overview of the experience of the SFDA in establishing its structure and organization from 2003 until it become an operating organization in 2009. He highlighted the challenges it faced in terms of infrastructure, processes, guidelines, and eservices. He presented statistics relating to SFDA regulatory submission meetings in 2010; only 55% of sponsors attended preorganized regulatory submission meetings, and in most cases the SFDA had not received prior notice of cancellation. This was deemed by the entire conference an area for radical improvement. The presentation also discussed the CTD structure as a new concept, with reviewers requiring more experience, and concluded with the necessity of training in all aspects of dossier review and assessment. Ctd and E-Ctd submission rebekah Logan, director of regulatory affairs, Eli Lilly, usa, informed the audience that the CTD is a useful standard for formatting drug registration documentation. The speaker encouraged simple electronic submission standards (NeeS) to reduce use of resources. Ms Logan stated that while using CTD, compliance with the ICH definition of CTD is critical and only then can using CTD benefit the industry, agencies, and patients. She encouraged agencies to minimize their expectations for requesting customized countryspecific documentation beyond the ICH CTD content and that instead could rely on source country approvals as an additional source for information and/or on manufacturing site inspections. Ms Logan provided examples of countryspecific requests that are not
9th Middle East Regulatory Conference p r o c e e d i n g s 531 aligned with the ICH CTD content and suggested removal from regulatory requirements of signed and stamped specification documents from the manufacturer; validation of analytical procedures; request for assays of API and degradation products, especially with raw data and chromatograms; container closure system description of packaging material; raw stability data; chromatograms; and inuse stability information. In conclusion, harmonization to ICH CTD structure for pharmaceutical regulatory dossiers is encouraged, and authorities within the Middle East region are on the path to being successful in this. t h e c h a n g i n g r e g u L at o r y e n V i r o n m e n t Following on from discussions of the structure of a regulatory dossier, discussing the changing regulatory environment provided the conference with a medium to reflect on the progress of the Middle East region in relation to harmonization, legislation, and operating principles and to look toward the future regulatory environment. rEguLatory CooPEration and harmonization: bEnEFits to PubLiC hEaLth dr Lembit rägo, Coordinator, Quality assurance and safety: medicines, department of Essential medicines and Pharmaceutical Policies, who, switzerland, gave a comprehensive review of the evolution and shifts in the regulatory paradigms giving focus to the importance, and growing need, of increased harmonization among regulators. He commented that the environment in which regulators operate continues to change, with the development of new technologies and globalization of R&D and the economic landscape as some of the examples given. Dr Rägo suggested that regulators should, through harmonization, focus on areas and activities where they can add value and best contribute to public health. Through the formation of effective networks between regulatory authorities the sharing of scarce resources Drug Information Journal and elimination of duplicate activities could be facilitated. His presentation highlighted the harmonization and collaboration initiatives WHO supports, such as being a partner in the WPRO initiative and WPRO support for harmonization in ASEAN. rEguLatory work sharing in thE middLE East dr hajed hashan, Executive director of Pharmaceutical Products registration department, sFda, saudi arabia, spoke on how he saw the region could further improve and share ideas going forward. Dr Hashan acknowledged the key elements of change that have occurred over the period of the last nine MERCs and how the environment has evolved. Looking forward, he identified areas that offered further opportunity for sharing: • Harmonization • Research • Training • Transparency • Cooperation between regulatory authorities on a global level During the discussion, Dr Hashan commented that it was important to understand that collaboration does not mean a decrease in resources. Before consolidating, there is a need to ensure that there are enough resources to progress and maintain collaboration. In addition, collaboration should not be viewed as a reflection on an inability to do it yourself but an opportunity to learn and avoid duplication. fa L s i f i e d m e d i c i n e s This subject area’s key goal was to emphasize and continue to reduce the public health risk posed by falsified medicines. The interaction between regulatory authorities and industry is key in targeting this goal of eradicating falsified medicines. This again provided significant debate during the conference. Four speakers were invited to share their views and experiences on this matter: dr Lembit rägo (Coordinator, Quality Assurance and Safety: Medicines, Department of Essential Medicines and Pharma
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