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Regulatory News WHO Drug Information Vol. 28, No. 4, 2014 Regulatory news Ebola curative – transfusions of whole blood or blood plasma from recovered patients Update on treatments and vaccines have been scheduled to be conducted in Liberia, in line with WHO technical The Ebola crisis has prompted an guidelines (4). unprecedented cooperation between regulators In September the European Medicines to support WHO and to advise on possible Agency (EMA) established an expert pathways for the development, evaluation and group to review available information approval of medicines to fight Ebola. Progress on Ebola experimental treatments – towards provision of treatments and vaccines is excluding convalescent therapies – and summarized below. invited developers to submit their data (5). In August 2014, a WHO-convened panel Vaccines had agreed unanimously that is ethically On 29–30 September, 70 experts acceptable to use of experimental attended a WHO-convened consultation medicines and vaccines under the on Ebola vaccines. They took stock of the exceptional circumstances of the Ebola many ongoing efforts to rapidly evaluate epidemic (1). In early September, WHO the safety and efficacy of Ebola vaccines convened a consultation on potential for deployment as soon as possible to Ebola therapies and vaccines (2). The critical frontline workers and ultimately to importance of supportive care and populations at risk in mass vaccination community response was stressed in this campaigns. Two candidate vaccines have and subsequent discussions. clinical-grade vials available for safety trials. (6) Treatments In October, WHO convened industry In September, more than 200 experts leaders and key partners to discuss trials from around the world met at WHO and production of Ebola vaccine (7). and agreed to prioritize convalescent Consensus was achieved to make results blood and plasma therapies for further available in December 2014, to begin investigation. Many questions remain to efficacy trials at the same time, and to be answered about the safety and efficacy scale up production in 2015. of convalescent therapies, the feasibility of Also in October the EMA gave its first implementation in countries with shattered scientific advice on a development plan health systems, and the prospects of for an Ebola vaccine, using a new ‘rolling scaling up therapy to curb the fatality rate review’ procedure for data assessment (2). To support implementation, WHO has and sharing of outcomes with healthcare issued new interim guidance on the use of decision-makers in affected countries (8). convalescent therapies for national health At the time of writing, safety trials of authorities and blood transfusion services vaccines were underway in the U.S., U.K., (3). The first clinical trials of – possibly Mali and Switzerland, and about to begin 459 Regulatory news WHO Drug Information Vol. 28, No. 4, 2014 in Gabon, Germany and Kenya.The two a diagnostic’s quality, safety and Swiss trials are coordinated by WHO, performance. (12) with testing done on healthy volunteers, some of whom will be deployed in the fight ► (1) WHO Statement, 12 August 2014. against Ebola in West Africa (9). (2) WHO. Ebola situation assessment - 26 September 2014. At the meeting of the African Vaccine (3) WHO. Use of Convalescent Whole Regulatory Forum (AVAREF) in early Blood or Plasma Collected from Patients November, delegates discussed Recovered from Ebola Virus Disease for collaborative mechanisms to fast-track Transfusion, as an Empirical Treatment clinical trial approvals and registration of during Outbreaks. Version 1.0, September Ebola treatments and vaccines in affected 2014. (4) WHO. Ebola situation assessment, 6 countries, and – importantly – reaffirmed November 2014. the need to build stronger health systems (5) EMA Press release, 26 September 2014. (10). (6) WHO. Experimental Ebola vaccines. 1 October 2014. Supportive care (7) WHO News release, 24 October 2014. Industry leaders and key partners have (8) EMA Press release, 29 October 2014. (9) WHO News release, 6 November 2014. emphasized that community engagement (10) WHO Essential Medicines and Health remains key to fight Ebola and have Products. African regulators’ meeting called onlocal communities, national looking to expedite approval of vaccines and governments, NGOs and international therapies for Ebola [web page]. organizations to scale up concerted (11) Bah EI, Lamah M, Fletcher T, Jacob ST, Brett-Major DM, Sall AA et al. Clinical activities urgently. (7). Meanwhile, a Presentation of Patients with Ebola Virus WHO-coordinated retrospective study has Disease in Conakry, Guinea. N Engl J Med. shown that supportive care, especially 2014; 5 Nov 2014. rehydration and correction of metabolic (12) WHO. Ebola situation assessment - 18 abnormalities, may contribute to patient November 2014. survival (11). Diagnostics Clinical trials transparency Quick and accurate diagnosis is key in fighting Ebola. WHO has launched two EMA adopts policy on publication urgent initiatives to accelerate the delivery of clinical reports of rapid, sensitive, safe and simple European Union – The EMA’s Ebola diagnostic tests to West African Management Board has unanimously countries. The first is a close collaboration adopted a new policy to publish the clinical of manufacturers, researchers, Médecins trial reports that underpin the decision- sans Frontières (MSF) staff, and the making on medicines. The policy will non-profit organization Foundation for enter into force on 1 January 2015 and Innovative New Diagnostics (FIND), will apply to clinical reports supporting and aims to support the development all applications for centralized marketing of suitable tests. The second is the authorizations submitted after that date. establishment of an emergency rapid According to the policy’s terms of use, review mechanism for assessing the reports cannot be used for commercial purposes. In the limited instances 460 WHO Drug Information Vol. 28, No. 4, 2014 Regulatory news where they may contain commercially can apply some or all of its provisions with confidential information, this will be immediate effect. Two related guidelines redacted in accordance with the principles and procedural guidance are also being outlined in the policy’s annexes. updated. The new policy will serve as a ► EMA Press release, 29 October 2014. complementary tool ahead of the implementation of the new EU Clinical Trials Regulation that will come into force EMA proposes harmonized clinical not before May 2016. Public access to trials plan for vaccine in children clinical reports will enable academics and European Union – The EMA has researchers to re-assess data sets, and proposed a single development plan will help to avoid duplication of clinical trial for new tetanus-diphtheria-acellular ► EMA Press release, 2 October 2014. pertussis vaccines that all pharmaceutical companies across the EU should follow. The proposal aims to avoid the Pre-market assessment duplication of similar clinical trials and the unnecessary exposure of children to EMA revises guidance on clinical testing. biosimilars As the schedules of child vaccinations European Union – The EMA has vary slightly between EU countries, a published its revised guideline on large number of fairly similar clinical trials biosimilars. The main change is that are currently conducted in children when a developers can now use a comparator new vaccine is being developed. The EMA product authorized outside the European collaborated with the European Centre for Economic Area (EEA) in certain clinical Disease Prevention and Control (ECDC) studies and in non-clinical studies to define a single schedule for clinical conducted in vivo. This new concept trials. A panel of public health vaccinology aims to avoid unnecessary repetition experts have endorsed the proposal. of clinical trials. The comparator must The proposed plan has been released be authorized by a regulatory authority for a three-month public consultation. with similar rigorous scientific and ► EMA News, 23 September 2014. regulatory standards to those of EMA, and the applicant must establish that the comparator is representative of the EMA pilot to seek patient views on reference medicine authorized in the EEA. medicines risks and benefits A biosimilar is a biological medicine European Union – The European that is similar to an already authorized Medicines Agency (EMA) has launched reference product (comparator). To obtain a pilot project to involve patients in the a marketing authorization the developer assessment of the benefits and risks of must demonstrate in studies that the medicines in its Committee for Medicinal biosimilar is as safe and effective as the Products for Human Use (CHMP). reference medicine, and meets the EMA’s Patients will be invited to present their quality requirements. views on medicines for which there is While the revised guideline will come an unmet medical need and where the into force as of 30 April 2015, applicants Committee has doubts on its regulatory 461 Regulatory news WHO Drug Information Vol. 28, No. 4, 2014 decisions at any stage of the product life decisions for priority diseases. On the other cycle. EMA has published a document hand, regulation of IVDs is still very limited outlining the principles of this approach. or absent in many countries. Read more in WHO Drug Information Vol. 28, No. 3, 2014 The first active substance included in on what WHO is doing to bring quality- this pilot project has been afamelanotide, assured IVDs to its Member
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