WHO Drug Information Vol. 29, No. 4, 2015 WHO Drug Information Contents Cooperation 460 Regulatory systems New Zealand working on new regulatory 435 CIOMS - A nongovernmental organization regime in official relations with WHO 460 Post-marketing control EMA initiative to improve patient registries 461 Collaboration and harmonization Pharmacopoeial standards ICH announces organizational changes 440 Ensuring the efficacy of a deworming ; China and WHO collaborate on medicines medicine: albendazole chewable tablets quality; Meeting of World Pharmacopoeias held in China; Regulators of United Kingdom and India sign agreement; EMA and WHO Quality of medicines share non-public information 446 The WHO CPP Scheme in today’s regulatory 463 Approved environment – is it time for change? Insulin degludec & insulin aspart : for diabetes mellitus; Efmoroctocog alfa : for haemophilia ;A Modified antihaemophilic factor (recombinant); Coagulation Factor X Safety news (human) : for hereditary Factor X deficiency; Patiromer : for hyperkalaemia; Elvitegravir & cobicistat 451 Restrictions & emtricitabine & tenofovir alafenamide : for HIV Mirabegron : contraindicated in patients with severe hypertension; infection; Uridine triacetate : for a rare hereditary metabolic disorder; Trifluridine & tipiracil : for advanced colorectal cancer; 451 Safety warnings Blinatumomab : for certain acute lymphoblastic leukaemias; Necitumumab : for advanced squamous non-small cell lung cancer; Cobimetinib : Proton pump inhibitors : subacute cutaneous lupus erythematosus; Antiviral combinations for metastatic melanoma; Irinotecan liposome injection : for advanced pancreatic cancer; Carfilzomib : for hepatitis C : liver injury; Daclatasvir hydrochloride for a rare type of blood cancer; Ixazomib : for multiple myeloma; Talimogene laherparepvec : for advanced melanoma; and asunaprevir : interstitial pneumonia; Vemurafenib : potentiation of radiation toxicity ; Crizotinib : Mepolizumab : for asthma; Osimertinib : for certain non-small cell lung cancers; Daratumumab : for multiple myeloma; heart failure; Fingolimod : skin cancer ; Aripiprazole : impulse control disorders; Sodium Cariprazine : for schizophrenia and bipolar disorder; Pitolisant : for narcolepsy; Naloxone nasal spray : for opioid polystyrene sulfonate : separate dosing to prevent interactions; Iodine-containing overdose; Idarucizumab : for reversal of dabigatran anticoagulant effect ; Patiromer : for hyperkalaemia; contrast agents: hypoactive thyroid in infants; 468 EMA Article 58 positive opinion 454 Known risks Pyronaridine-artesunate – paediatric Magnesium oxide : hypermagnesaemia in older patients; Canagliflozin : antimalarial formulation decreased bone mineral density; Mycophenolate : avoid exposure in pregnancy; Ceftriaxone : acute generalised exanthematous 469 Extensions of indications pustulosis; Roxithromycin : pseudo–membranous colitis, cardiac effects ; Strontium : cardiovascular risks; Clozapine : severe Anthrax vaccine adsorbed : for post-exposure protection ; Ipilimumab : to prevent melanoma recurrence; neutropenia; Dimethyl fumarate and other fumarate- Nivolumab : for renal cell cancer; Pembrolizumab : for advanced non-small cell lung cancer; containing medicines : new monitoring measures ; 469 WHO endorsements 456 Unchanged recommendations Global Ebola virus and antibody reference Clopidogrel : no increased risk of death; Human papillomavirus vaccines : benefits outweigh standards; Malaria vaccine to be delivered in risks; Entacapone : no clear evidence of cardiovascular events; pilot projects 457 Removal of class warnings HIV medicines : class warnings about lipodystrophy and lactic acidosis removed Publications and events 457 Safety reviews started 471 Development 458 Packaging Sustainable development goals aim at health Improved packaging for dementia treatments; for all 458 Medicines quality 471 Access to medicines Apotex : Canada import ban lifted, product re-testing imposed; Dibotermin alfa-containing implant kit : suspended in Europe; WHO publishes updated essential medicines 459 Falsified product alert lists; Medicines Patent Pool expands Falsified emergency contraceptive circulating mandate to hepatitis C and tuberculosis; First in East Africa patent pool licence for a hepatitis C medicine ; Controlled substances not accessible to all in need; Inefficiencies in the global insulin Regulatory news market 460 Pre-market assessment Accelerated access pathways in Europe Continued 433 WHO Drug Information Vol. 29, No. 4, 2015 Continued 474 Health and trade 480 WHO matters European Council resolution defends public WHO launches independent assessment of health interests; HAI/MSF report on EU trade snake antivenoms; WHO Expert Committees policies and public health; WTO extends on medicines meet in Geneva ; New web site drug patent exemption for least-developed on substandard and falsified medicines countries; New WHO publication about trade and health 475 Diseases Consultation documents Hepatitis world summit adopts 482 The International Pharmacopoeia Declaration; Malaria death rates plunge but 482 Cycloserine risk remains; Tuberculosis remains a public 486 Cycloserine capsules health challenge ; Ebola still a public health 490 Ceftriaxone sodium emergency; Measles immunization gap 493 Ceftriaxone for injection persists 477 Antiretroviral treatment WHO recommends treatment for all people ATC/DDD classification living with HIV ; Updated optimal list of ARVs 496 ATC/DDD classification (temporary) for children 501 ATC/DDD classification (final) 478 Antibiotics International summit on antibiotic resistance; Use of veterinary antibiotics International Nonproprietary in Europe; Multi-country survey reveals Names (INN) misconceptions on antibiotic resistance 479 Lists and manuals 503 Proposed INN: List 114 Indicators to assess pharmacovigilance systems; Specifications for selected HIV diagnostics 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) MHLW Ministry of Health, Labour and Welfare, Japan 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 Pharmaceuticals and Medical Devices Agency, Japan (www.pmda.go.jp/english/index.htm) 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. 434 WHO Drug Information Vol. 29, No. 4, 2015 Cooperation CIOMS - A nongovernmental organization in official relations with WHO The Council for International Organizations of Medical Sciences (CIOMS) aims to facilitate and promote international activities in the field of biomedical sciences, in collaboration with the United Nations (UN) and WHO. CIOMS has initiated and coordinated major long-term programmes around the topics of Health Policy, Ethics and Human Values - An International Dialogue and International Nomenclature of Diseases. Currently the main activities are within the areas of bioethics and drug development and use. Background (ICH) and the International Federation The Council for International of Pharmaceutical Manufacturers & Organizations of Medical Sciences Associations (IFPMA). (CIOMS)1 was established by the World Health Organization (WHO) and the Activities United Nations Educational, Scientific and In its more than six decades of existence, Cultural Organization (UNESCO) in 1949. CIOMS has fostered a unique cooperation Its offices are located in Geneva, close between specialized international medical to WHO and the UN Palais des Nations. associations and societies and other CIOMS has enjoyed excellent relations relevant stakeholders, and has promoted with both its “parents” since its creation global activities in certain areas of the and is in official relations with WHO and medical sciences whenever international an associate partner of UNESCO. cooperation is called for. CIOMS seeks Through its membership, CIOMS to take into account the priorities, needs is representative of the biomedical and resources of both industrialized and scientific community. The members of low-and-middle income countries (LMICs). CIOMS include international and national As a nongovernmental organization, it professional associations, representing is also able to draw on the considerable many of the biomedical disciplines, expertise existing in the research- national academies of sciences and based pharmaceutical industry where medical research councils (Annex 1). appropriate. WHO is represented by at least one senior staff member in all CIOMS Bioethics working groups. CIOMS also cooperates In the field of biomedical research with the International Council for involving human subjects, the World Harmonisation of Technical Requirements Medical Association (WMA) and CIOMS for Pharmaceuticals for Human Use have been among the key international actors. In addition, the WHO input to 1 www.cioms.ch 435 Cooperation WHO Drug Information Vol. 29, No. 4, 2015 CIOMS activities in the field of research A public