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

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526 p r o c e e d i n g s Ball, Fallows nal comparison of the regulatory review process in the GCC was also shared with the conference. Jordan Food and drug administration dr Leila Jarrar, drug directorate director, Jordan Fda, presented the JFDA’s structure and department with focus on their points of strength due to qualified staff, scientific expertise, openness to regional and international meeting and exchange, and the increase in drug exports over imports. She spoke in depth about regulations implemented by the JFDA since MERC 2008, including guidance and legislation on biosimilar registration, clinical trials, and pharmacovigilance (JFDA legislation and guidelines are available on www.jfda.jo). JFDA’s future visions and targets were to be strategic, vigilant, quick, and visible, and Dr Jarrar actively promoted the harmonization of the regulatory guidelines in the region, which are in line with those of ICH. iranian nationaL drug and Food Laboratory dr mahmoud alebouyeh, head of the biological Laboratory of the iranian Food and drug Control Laboratory, presented new regulations in Iran for contract manufacturing of biopharmaceutical products. These guidelines are meant to encourage biopharmaceutical companies to invest in manufacturing facilities in Iran to produce finished drug products or at least some aspect of drug product manufacture (96% of biopharmaceutical products are locally manufactured in Iran; all information is available on www.fdo.ir). He spoke about the biosimilar registration process and pointed out the current local manufacture of biosimilar and other biological products is on the increase, with growing numbers of Iranianbased facilities. The pre and postmarketing surveillance was the last point highlighted by Dr Alebouyeh when he clarified the Iranian pharmacovigilance system and highlighted the in creasing number of adverse drug reports over the years. saudi arabia Food and drug authority dr hajed m. h. hashan, Executive director of Pharmaceutical Products registration department of the saudi arabia Food and drug authority (sFda), outlined the vision of the SFDA to become the leading drug regulatory authority in the Middle East. Dr Hashan informed the conference about the progress in the SFDA’s infrastructure, organization, and operational processes since its inception in 2009 (for further information see www.sfda.gov.sa). Furthermore, he pointed out that the SFDA has undertaken further internal projects (eg, drug registry procedure, counterfeit detection, ecoma, LIMS system, electronic tracking systems), all with the goal of the SFDA’s vision. More detailed guidance and legislation are being produced by the SFDA for biotechnology products. Dr Hashan highlighted the need to harmonize the regulatory environment throughout the Middle East and stressed the importance of cooperation between the Middle East regulatory authorities to streamline regulatory requirements and submission formats for the benefit of the whole region. guLF CooPEration CounCiL: drug rEgistration dr hajed m. h. hashan, on behalf of the gCC-dr, gave an overview of the members, regulatory initiatives, mission, scope, regulatory processes, and procedures of the GCCDR. All related information can be found at www.sgh .org.sa. He pointed out that the approval timelines have increased dramatically in the past two years due to limited human resources within the GCCDR and that a dramatic increase in regulatory submissions has occurred, with the consequence being a significant increase in good manufacturing practice compliance inspections. a ComParison oF rEguLatory rEviEw ProCEssEs and thE FaCtors inFLuEnCing thE QuaLity oF dECision making in gCC statEs dr reem al Essa from the welsh school of Pharmacy, Cardiff university, uk, presented
9th Middle East Regulatory Conference p r o c e e d i n g s 527 to the conference her study, comparing regulatory review processes and factors influencing decision making in the GCC. The study focuses on regulatory affairs processes and the measures used to build quality into the regulatory review process, and how this improves decisionmaking processes in GCC regulatory authorities. From Dr Essa’s findings, her conclusions were that the majority of GCC authorities should deploy some form of training and continuous education programs for their reviewing staff, that joint reviews, as part of the GCCDR system, should take place, and that a wide range of activities should occur to improve communication with the pharmaceutical industry and transparency with the public. Her key recommendations were adoption of a standardized regulatory assessment template and parallel assessment of sample analysis and pricing with the scientific assessment process to improve patients’ access time, engagement of external quality audits by accredited external certification bodies, and improvement of transparency to increase confidence in their review practices. g L o b a L r e g u L at o r y e n V i r o n m e n t a n d o p p o r t u n i t i e s f o r t h e m i d d L e e a s t This session was to raise awareness of the global regulatory environment outside the Middle East and to present an overview of its impact on local Middle Eastern regulatory authorities. Presentations from both aspects were given with key recommendations in variation management for consideration in the future. variation managEmEnt and FuturE trEnds in thE Eu dr Christa wirthumer-hoche, head of marketing authorization of medicinal Products and Lifecycle management, agEs Pharmmed, austria, presented the new EU variation guidelines that came into force at the beginning of 2010. This included the different classification of changes, that is, Type IA (minor variations), Type II (major changes), and Type IB (by Drug Information Journal default, ie, neither a Type IA or II nor an extension). The objective was to introduce simpler and more flexible guidelines to reduce the administrative burden for both the industry and the authorities. This new variation guideline covers changes to all EU procedures (centralized, mutual recognition, decentralized, national) and is applicable to both human and veterinary products. The guidelines are published on the DG Health website (EC 1234/2008) and should be referred to for a better understanding of the classification of the different variations and the regulatory conditions to be fulfilled. variation managEmEnt in thE middLE East: LoCaL ExPEriEnCEs dr ramy behbehani, a registration and release superintendent from the kuwait Food and drug Control administration (kFdC), started by providing a definition of a variation and the need for a change in the requirements to protect public health by better use of medicines. Enabling faster implementation of scientific progress for the benefit of patients should be industry and regulators’ goal. He explained how variations are currently managed in Kuwait, referencing Guidelines Decree 302/80 (recently amended by adding annex no. 7), which categorized each variation according to its type and also provided a list of regulatory requirements to be submitted for the change. The categories of the variations were in line with those adopted by other competent Middle East regulatory authorities. In terms of approvals, according to the current guidelines, the market authorization holder should wait for approval from the KFDC before implementing the proposed changes. His proposal for the conference to consider, in line with EU variation guidelines (tell and do, tell, wait and do process) and the EFPIA position paper on the management of variation, was to harmonize with the EU regulations so as to avoid duplication, simplify regulatory review, and speed up the approval process.
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