WHO Drug Information Vol. 28, No. 4, 2014 WHO Drug Information Contents 461 Pre-market assessment WHO Prequalification EMA revises guidance on biosimilars 425 Building quality-assured manufacturing ; EMA proposes harmonized clinical trials capacity in Nigeria plan for vaccine in children; EMA pilot to seek patient views on medicines risks and benefits; Australia to recognize EU conformity Pharmacopoeial standards assessment for medical devices 431 Global specifications: the example of 462 Pharmacovigilance capreomycin Canada passes Vanessa’s Law; EU project on using smartphones for drug safety Medicines quality assurance information; EMA expands public web access to reports on suspected side effects 434 A harmonized self-assessment tool for ; Australia, Switzerland create web portals procurement agencies to report adverse reactions; New MHRA guidance on reporting adverse drug reactions Safety news in children 464 Organizations 448 Unchanged recommendations Australia and New Zealand to keep separate Testosterone : cardiac risk not confirmed; Agomelatine : strengthened advice to monitor liver function; regulatory authorities 449 Restricted use 464 Veterinary medicines Intravenous nicardipine : only to control high blood pressure in specialist settings; Bromocriptine : not for pre menstrual syndrome or benign breast EU proposes veterinary medicines legislation disease; Colistimethate sodium : reserve for serious infections resistant to standard antibiotics; Valproate : not to be used in pregnancy; Sulfur revisions ; Sales of veterinary antibiotics in hexafluoride : not to be used with dobutamine in certain patients; Europe decrease 451 Safety warnings 465 Approved Ivabradine : heart problems; Carvedilol : Rare severe skin reactions; Voriconazole : phototoxicity and squamous skin Netupitant and palonosetron: for chemotherapy-induced nausea ; Naloxegol : cancer; Immunoglobulins : rare but serious risk of blood clots; Simeprevir : increased bilirubin may cause serious outcomes; Basiliximab : for opioid-induced constipation ; Dulaglutide : for type 2 diabetes; Antihaemophilic factor cardiac adverse events when used off-label in heart transplants; Ustekinumab : serious skin conditions; Ponatinib : blood vessel blockage; Diclofenac and (recombinant), porcine sequence : in acquired haemophilia A other NSAIDs : cardiovascular risks and liver damage; Denosumab : osteonecrosis of the jaw and hypocalcaemia; Pregabalin : ; Nonacog gamma : in haemophilia B; Afamelanotide : for erythropoietic liver damage; Zopiclone : next-day impairment; Bupropion : serious cardiovascular events; Galantamine protoporphyria; Darunavir & cobicistat : for HIV infection; Ledipasvir & hydrobromide : serious skin reactions; Dimethyl fumarate: rare brain sofosbuvir : for hepatitis C infection; Dasabuvir : for hepatitis C infection; Ombitasvir & infection; Omalizumab: slightly increased risk of heart and brain adverse events; paritaprevir & ritonavir : for hepatitis C infection; Meningococcus B 457 Risk minimization measures vaccine; Pembrolizumab : for advanced melanoma; Ramucirumab : for gastric Methylphenidate : web-based prescribing guide; cancer; Secukinumab : for plaque psoriasis; Pirfenidone : for idiopathic pulmonary fibrosis; Nintedanib : for non-small cell lung cancer / idiopathic pulmonary fibrosis; 457 Medicines review started Olaparib : for a subtype of ovarian cancer; Blinatumomab : for a rare form of acute lymphoblastic leukaemia ; Abuse-deterrent 458 Manufacturing quality issues hydrocodone : single-entity, extended release product; Health Canada restricts imports from various 469 Labelling changes approved Indian sites Ketoconazole : for Cushing’s syndrome; Ulipristal : emergency contraceptive without prescription; 458 Site review started Publications and events Regulatory news 471 Access to treatment 459 Ebola 2014 Access to Medicines Index Update on treatments and vaccines launched; New Lancet Commission on Essential Medicines Policies; WHO 460 Clinical trials transparency invites hepatitis medicines for EMA adopts policy on publication of clinical prequalification; Antiviral Therapy special reports issue on access to HIV treatment Continued 423 WHO Drug Information Vol. 28, No. 4, 2014 Continued 472 Intellectual property Consultation documents Interagency symposium on access to medical technologies; WHO report on patent status 476 The International Pharmacopoeia of hepatitis medicines; NIH and FDA win top 476 Flucytosine award for meningitis vaccine licensing deal 480 Flucytosine intravenous infusion 473 Medicines for children Improving medicines for children in Canada ATC/DDD Classification 473 Medicines use 482 ATC/DDD Classification (Temporary) Study shows better drug and antibiotic use 484 ATC/DDD Classification (Final) where there is policy implementation 474 WHO matters Two WHO Expert Committee meetings International Nonproprietary held; WHO prequalification of medicines 2013 Names annual report 485 Proposed List No. 112 Abbreviations and web sites CHMP Committee for Medicinal Products for Human Use (EMA) EMA European Medicines Agency (www.ema.europa.eu) EU European Union FDA U.S. Food and Drug Administration (www.fda.gov) Health Canada Federal department responsible for health product regulation in Canada (www.hc-sc.gc.ca) MHRA Medicines and Healthcare Products Regulatory Agency, United Kingdom (www.mhra.gov.uk) Medsafe New Zealand Medicines and Medical Devices Safety Authority (www.medsafe.govt.nz) PRAC Pharmacovigilance Risk Assessment Committee (EMA) PMDA Pharmaceutical and Medical Devices Agency, Japan (www.pmda.go.jp/english/index.htm)l Swissmedic Swiss Agency for Therapeutic Products (www.swissmedic.ch) TGA Therapeutic Goods Administration, Australia (www.tga.gov.au) U.S. United States of America Note: The online version of this issue (available at www.who.int/medicines/publications/druginformation) has direct clickable hyperlinks to the documents and web pages referenced. 424 WHO Drug Information Vol. 28, No. 4, 2014 WHO Prequalification Building quality-assured manufacturing capacity in Nigeria As a fast growing economy and large provider of goods and services to countries in the region, Nigeria is poised to expand its pharmaceutical production to achieve self-sufficiency in essential medicines and compete on regional and global markets. To this end, government health authorities and local manufacturers requested WHO support and technical assistance to prequalify several locally produced medicines, as a way to fast-track the building of local capacity to manufacture medicines according to international quality standards. An integral part of the process is the strengthening of national regulatory capacity to enforce these standards on an ongoing basis. The Nigerian quest priority diseases meet global standards While no medicines manufacturer in West of quality, safety and efficacy. By Africa has so far achieved prequalification evaluating needed pharmaceutical of a pharmaceutical product by the World products – including those produced in Health Organization (WHO), Nigeria is countries with limited regulatory capacity attempting to change the status quo. A – the WHO prequalification team (WHO/ number of companies belonging to the PQT) provides a basis for national and Pharmaceutical Manufacturers Group international procurers to make cost- of the Manufacturers Association of effective choices among finished products Nigeria (PMG-MAN) are working to reach of assured quality. a manufacturing quality standard that WHO/PQT has increasingly engaged will enable them to have some of their in activities that go beyond dossier products WHO-prequalified and apply for assessment and site inspections. The international medicines tenders. team is training national regulators, The project has been supported by the providing guidance to manufacturers, Nigerian government and by the National facilitating registration in countries Agency for Food and Drug Administration and supporting post-procurement (NAFDAC). WHO was approached to quality control. The experts who provide technical assistance to both advise manufacturers in preparing manufacturers and regulators especially in prequalification submissions work the areas of good manufacturing practice independently of the prequalification and dossier submissions in line with WHO dossier assessment and inspection and international standards. groups. The main objective of these activities is to disseminate sound Role of WHO knowledge and practices and to ensure The WHO prequalification programme that all the actors work together according aims to ensure that medicines for 425 WHO Prequalification WHO Drug Information Vol. 28, No. 4, 2014 to the same international quality 70% of its medicines, mainly from Asia, standards. Europe and the Americas. From the WHO perspective, the In terms of the regulatory environment, Nigerian project is in line with these aims. the National Agency for Food and Drug Given the importance of Nigeria in its Administration and Control (NAFDAC) geo-economic region, it is hoped that has in recent years enacted numerous increased production of quality medicines enforcement activities to combat in the country will also lead to better substandard and counterfeit medicines. It quality medicines in West Africa as a has also consistently worked with WHO to whole. strengthen its quality control and post- marketing monitoring of pharmaceuticals. Snapshot of Nigeria’s But challenges persist, which are largely pharmaceutical landscape related to insufficient capacity to ensure Nigeria