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

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528 p r o c e e d i n g s Ball, Fallows p r e - a n d p o s t m a r K e t i n g s a f e t y a n d p h a r m a c o V i g i L a n c e a s a t o o L t o m o n i t o r p h a r m a c e u t i c a L p r o d u c t s This session’s subject matter was to discuss tools that contribute to the continual monitoring of pharmaceutical products in relation to patient safety. This provided significant debate during the conference as both industry and regulatory authorities prioritize patient safety as key in pharmaceutical development. sFda PharmaCovigiLanCE uPdatE dr ghazi s. saeed, director of Pharmacovigilance department, sFda, saudi arabia, highlighted that establishing a postmarketing surveillance program is a strategic imperative to contribute to the protection of public health. This can be achieved by monitoring the safety and quality of medicines and by ensuring access to uptodate safety information on medicines to patients and health providers. During his presentation, Dr Saeed gave an overview of SFDA achievements and a summary of the reporting process and tools. Besides the National Pharmacovigilance Center (NPC) creation (which has been operational since March 2009), awareness measures were taken to improve the reporting culture, and guidelines were issued for pharmacovigilance obligations and reporting. One of the strategies for making the reporting plan successful is the organization of pharmacovigilance campaigns, and so far 37 workshops have been held and more than 4,000 health care professionals trained in adverse drug reactions (ADRs) and reporting across the country with the help of 62 coordinators from major hospitals. Dr Saeed illustrated the reporting figures, since the deployment of NPC, consisting of serious events. Dr Saeed went on to explain the role of the pharmacovigilance department’s advisory committee. The committee’s main responsibilities are assessing signal detection, periodic safety update reports, and implementing consequential actions on labeling to revoke marketing au thorizations based on safety concerns. The success of this committee is due to its regular meetings and the extensive training of the department’s staff. Dr Saeed concluded that tackling the underreporting of ADRs is imperative and continuing efforts in safety monitoring will contribute to the future safety of patients. PharmaCovigiLanCE: rEviEw oF intErnationaL aPProaChEs and trEnds sten olsson, Chief who Programme officer, uppsala monitoring Centre, who Collaborating Centre for international drug monitoring, sweden, introduced his presentation by reminding the audience that pharmacovigilance covers adverse effects but also product quality, inadequate use, and safety challenges of mass treatment campaigns. He pointed out that spontaneous reporting is the backbone of any pharmacovigilance system and the value for having collected data over the world. In the last 15 years the number of member countries of the WHO program for international drug monitoring has more than doubled (104 including Oman, Iran, Egypt, Jordan, Saudi Arabia, and Iraq), allowing a significant growth of the WHO database (VigiBase, storing around 6,000,000 individual safety case reports), but the ongoing challenge is to expand member countries and reporting. Mr Olsson detailed the different national system approaches, in terms of organization, affiliation, and regulation. VigiBase allows comparisons in terms of rate of reporting to be made. Despite some Middle East countries having a more dynamic reporting rate, it is unfortunate that the overall rate remains low compared to global trends, and the frequency of reporting to VigiBase needs to increase across the Middle East region. In conclusion, having functional pharmacovigilance systems becomes a necessity with the increase of global access to medicines and is supported by global health initiatives and WHO. Mr Olsson informed the conference that
9th Middle East Regulatory Conference p r o c e e d i n g s 529 as part of a joint WHO/Global Fund strategy, facilitating documents have been made available, and WHO is committed to providing relevant services to all countries. The demand for training remains a bottleneck where capacity scaleup is needed. t h e r o L e o f r e s e a r c h a n d d e V e L o p m e n t i n pat i e n t a c c e s s t o n e w m e d i c i n e s The theme of this subject was to explore biological medicines and their associated regulatory complexity. Speakers from industry and regulatory authorities gave compelling presentations on biological and biosimilar products. biosimiLar guidanCE: Luxury or nECEssity dr thomas schreitmueller, head, regulatory Policy and strategy biologics, hoffmann La roche Ltd, basel, switzerland, explained that biologics are large and very complex molecules and that their manufacturing process confers unique properties that make them not identical to the original molecule. He shared examples of modifications that can take place with biologics (deamidation, glycation, sialylation, methionine oxidation, etc) inherent or due to the manufacturing process, which may result in approximately 10 8 potential variants. Dr Schreitmueller explained that manufacturers of biological products must comply with an extensive set of regulations and guidance documents to ensure quality and safety of biological products, giving the US FDA, EMA, and ICH as examples. The speaker concluded that all biosimilars must undergo stepwise and headtohead comparisons, including comparative quality, nonclinical, and clinical studies to the same reference requested. He informed the conference that if major differences are found in the quality, nonclinical, and clinical studies, the product should not be considered similar and, therefore, other options for its further development should be considered (eg, full development). Dr Schreit mueller shared that countries adopting EMA or WHO guidance will have robust biosimilar approval pathways. Drug Information Journal biosimiLar mEdiCinaL ProduCts: Eu ExPEriEnCE and PErsPECtivEs Pr Jean-hugues trouvin, bwP Chair, Ema, and scientific advisor for biological/biotech products, aFssaPs, France, highlighted the regulatory framework fact that in the 2000s, many marketing authorizations of biological products expired (hGh, EPO, GCSF, etc) and the regulators were obliged to elaborate a status of biosimilars in Europe. This was because biologicals are complex at molecular levels and characterization and quality controls are complex as a consequence. Therefore the bioequivalence parameters used for assessing generics are not sufficient and relevant for biologicals. In Europe, the legal framework for biosimilars was introduced in 2003. Guidelines for quality, nonclinical, and clinical studies to accompany biosimilar status were presented. Pr Trouvin focused his presentation on the biosimilar concept and the comparability exercise. In conclusion, biosimilar does not mean generic. “Bio” means that this is a biological product, with all its complexity and consequences in terms of safety and efficacy. It is not recommended to switch patients from one biological product to another without therapeutic justification. The biosimilarity concept as well as the comparability program are not aimed at concluding that the two products are identical. “Similar” indicates the product’s administrative and regulatory status. sPECiFiCitiEs oF thE dEvELoPmEnt and rEgistration oF biosimiLars in EuroPE dr david uguen, Executive director of voisin Consulting Life sciences, France, focused his presentation on the biosimilar dossier content and the differences that may occur between the reference biological product and the biosimilar. Several biosimilar products are registered and marketed in Europe, and many more will come. A biosimilar is a biological product, similar to a reference biological medicinal product, is not a generic medicinal product, and requires the conduct of nonclinical and clinical studies be
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