WHO Drug Information Vol. 31, No. 3, 2017 Regulatory news Regulatory news Pre-market assessment of adverse events in relation to stopping a trial or progressing to the next dosing level. Strategic approach to development ► EMA Press release, 25 July 2017. of children’s medicine European Union, United States of America – The EMA and the U.S. FDA have finalized Generic products in the U.S. their joint proposal to promote the use of United States of America – The FDA has innovative approaches in the development taken two steps to expedite market entry of of medicines for Gaucher disease. The needed generic medicines. These actions are proposed strategies can apply to medicines among the first taken under the Agency’s development for rare diseases in children in Drug Competition Action Plan announced general. in late May. The strategy document encourages Firstly, to encourage generic drug medicine developers to make better use development, the FDA posted a list of of extrapolation of available clinical data branded drugs that have no listed patents or from adults to children through modelling exclusivities and for which the agency has and simulation, and to conduct multi-arm, yet to approve an Abbreviated New Drug multi-company clinical trials on several Application (ANDA). The Agency intends new medicines at the same time, with the to expedite the review of generics on this same control arm serving more than one list, which will be refined and updated medicine under evaluation. The overall periodically. aim is to reduce the number of patients in Secondly, the FDA has announced a clinical trials while maintaining high quality change to its policy on prioritizing the standards, thus reducing the burden on review of needed generics. The review children and their families. of applications for a given medicine will ► EMA News, 3 July 2017. be expedited until there are three FDA- approved generics for that medicine. This policy change is based on data indicating Revised EMA clinical trial guidelines that significant price reductions occur when European Union – The EMA has released its there are multiple FDA-approved generics revised guidelines for first-in-human clinical available. trials. The revision takes into account the ► FDA News release, 27 June 2017. increasing complexity of trial protocols. It provides guidance on the calculation of the starting dose, subsequent dose escalations Joint EU assessment platform and criteria for the maximum dose. European Union – The EMA and the Guidance is also provided on criteria to stop European Network for Health Technology a study, the rolling review of emerging data Assessment (EUnetHTA) have launched especially regarding safety, and the handling a new joint platform that will facilitate 419 Regulatory news WHO Drug Information Vol. 31, No. 3, 2017 alignment of data requirements with The sample panel consists of plasma evidence being generated for both samples from anonymous individuals regulators as well as the bodies that provide infected with Zika, West Nile, or dengue recommendations to payers and other viruses. Although the panel is not for decision-makers. research purposes, diagnostic developers The platform will enable medicine can use these samples to assess whether their developers to obtain simultaneous, tests can help distinguish recent Zika virus coordinated advice and health technology infection from infection with West Nile or assessment bodies. Patient representatives dengue viruses. Using the same serological will be involved in parallel consultations on panel to evaluate different devices available a routine basis. The improved consultation, under Emergency Use Authorization (EUA) coordination and streamlined logistics are will help public health professionals expected to lead to more robust outcomes. compare the performance of different Zika ► EMA Press release, 4 July 2017. virus tests. The FDA panel is available to developers who have interacted with the Agency through the pre-EUA process and Emergency importation list have devices that are in the final stages of Canada – Health Canada has published an validation. Other developers interested in initial list of medicines for which there is requesting a panel may contact the Agency. an urgent public health need, and which ► FDA News release, 17 August 2017. are authorized for sale in the U.S., the EU or Switzerland, but not yet in Canada. Health Canada will permit these drugs to be Post-market monitoring imported for use in Canada. Provisions are in place for reporting of adverse reactions EMA platform gains trade mark and organizing recalls. European Union – The EU Intellectual The initial list includes medicines to Property Office (EUIPO) has approved the treat opioid use disorder and tuberculosis. registration of the name “EU PAS Register” Medicines will remain on the list for one as a European Union trade mark. year, renewable if there is a continued need The EU electronic Register of Post- for access. Additional medicines may be Authorisation Studies (EU PAS Register) was added to the list in the future, for example to developed through the European Network treat pandemic viruses or to address other of Centres for Pharmacoepidemiology public and military health emergencies. and Pharmacovigilance (ENCePP), which ► Health Canada News release, 28 June 2017. is coordinated by EMA. Launched in November 2010, this openly accessible platform currently includes information Standardized testing panel for Zika on more than 1 100 observational post- United States of America – The FDA has authorization studies, of which about a third made available a panel of human plasma are finalized. The trade mark will reinforce samples to aid in the regulatory evaluation of the EMA’s legal control over the name of the serological tests to detect recent Zika virus platform and its content. infection. ► EMA News, 7 August 2017. EU PAS Register® 420 WHO Drug Information Vol. 31, No. 3, 2017 Regulatory news Automated FDA field alert reports reports had been issued in July 2015, and United States of America – After the CDSCO had provided companies with a successful completion of a four-year pilot checklist of GMP and GLP requirements as phase, the FDA has released a new version specified under Schedule M and Schedule of its automated Form FDA 3331a for L-1 of the Drugs and Cosmetics Act and electronic submission of field alert reports Rules of India. However, CDSCO is yet for pharmaceutical products. The new to receive self-inspection reports from form does not require signatures, requires manufacturers. no additional software or licenses beyond ► CDSCO Notice, 9 August 2017. Adobe Acrobat Reader and an email client, and enables the FDA to import data directly to its systems. Collaboration Field alert reports enable the regulators to quickly identify quality defects in distributed China Food and Drug products that may present a potential Administration joins ICH safety threat. The Agency is working on Montreal – At its meeting held in Montreal, the technical requirements for receiving Canada on 27 May to 1 June 2017, field alert reports as part of the electronic the Assembly of the The International Common Technical Document (eCTD) Council for Harmonisation of Technical through the electronic submissions gateway. Requirements for Pharmaceuticals for ► FDA Notice to Industry, 15 June 2017. Human Use (ICH) approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and the Pharmaceutical GMP compliance Inspection Co-operation Scheme (PIC/S) as a new Observer. With these new parties, Indian manufacturers to submit ICH now has 14 members and 23 observers. self-certification Full details are available on the ICH website1. India – The Drugs Controller General At the meeting the ICH Assembly of India has issued a notice requesting also agreed to begin work on two new pharmaceutical manufacturers to submit topics: a harmonized guideline on the use their self-assessment reports and self- of extrapolation in children’s medicine certification of compliance with good development, and revised general manufacturing practice (GMP) and good considerations for clinical trials. The laboratory practice (GLP) requirements Assembly further adopted new guidance to the State Licensing Authorities and documents and made some revisions to to the Central Drugs Standard Control its Articles of Association and rules of Organization (CDSCO) by 30 August 2017. procedure to keep operations streamlined The notice states that issues related to the with a growing number of members and possibility of self-certification, followed by observers. third-party certification and detailed audit, ► ICH Press release, 19 June 2017. have been deliberated at the highest level. CFDA News, 20 June 2017. An earlier notice requesting mandatory self-audits and submission of self-assessment 1 http://www.ich.org/about/membership.html 421 Regulatory news WHO Drug Information Vol. 31, No. 3, 2017 U.S.-EU cooperation in inspections consolidated management committee is The European Commission (EC), the U.S. planned for June 2018. FDA and the EMA have signed a new The agreement follows an in-depth confidentiality commitment that allows review of various governance models. the US regulator to share non-public and The consolidation is expected to realize commercially confidential information several opportunities, including: enabling – including trade secret information a shared vision for information exchange relating to medicine inspections – with and regulatory cooperation;