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WHO Drug Information Vol WHO Drug Information Vol. 32, No. 2, 2018 WHO Drug Information Contents Regulatory networks 210 Databases Japan: Medicines use in children ; U.S.: 189 Update on the WHO-National Control Mobile app launched Laboratory Network for Biologicals 211 Collaboration Treaty for African Medicines Agency signed ; API inspection programme ; PIC/S updates Medicines use ; 9th Meeting of World Pharmacopoeias 213 Under discussion 194 The Prescribing Safety Assessment 214 Approved Fostamatinib ; Avatrombopag ; Tildrakizumab ; Erenumab ; Lofexidine Safety news ; Pegvaliase ; Inotersen 215 New formulation 199 Safety warnings Fosnetupitant and palonosetron injection Azithromycin ; Tosufloxacin ; Dolutegravir 215 Extensions of indications ; Leaking vaccine syringes; Pembrolizumab, Brentuximab vedotin ; Blinatumomab atezolizumab ; Filgrastim and other G-CSFs ; Dabrafenib with trametinib ; Fingolimod ; Denosumab ; Lamotrigine ; Veterinary ; Tofacitinib ear gel 216 Biosimilars 202 Known risks Epoetin alfa ; Trastuzumab ; Pegfilgrastim Anagliptin, linagliptin, teneligliptin ; Selexipag ; Infliximab; Adalimumab ; Tolvaptan ; Oral benzocaine products 217 Diagnostics 203 Updated recommendations Mass spectroscopy test for Candida auris Ulipristal; Antimicrobials ; Dengue 218 Negative opinions vaccine; Daclizumab Betrixaban; Abaloparatide; Neratinib 205 Other updates Hydroxyethyl starch; Quinolones and fluoro- quinolones Publications and events 206 Reviews started Omega-3 fatty acid medicines ; Ulipristal 219 Research and development ; Methotrexate; Metamizole; Curcumin- “Disease X” added to WHO research priority containing supplements list; Vaccines for emerging pathogens 207 Falsified medicines 219 Access to medicines Falsified hepatitis B vaccines circulating in European Parliament resolution ; The role of Uganda the pharmacist 220 Pharmaceutical waste management Pharmaceutical pollution and AMR; Medical Regulatory news waste in India increases 221 Diagnostics 208 Guidance First WHO essential diagnostics list EU: Good pharmacogenomic practice; U.S.: 222 Disease updates Genomic-based tests; UK: Data integrity Ebola ; Dengue ; Yellow fever; Cholera 209 Pre-market assessment ; Hepatitis C; Tuberculosis ; Non- Australia: New regulatory pathways ; EU: Two communicable diseases; HTLV-1 years of PRIME Scheme 225 WHO updates 210 Medical devices 71st World Health Assembly; WHO IMDRF meeting held; Canada: Disinfectants prequalification updates and sterilants reclassified 228 Upcoming events Continued 187 WHO Drug Information Vol. 32, No. 2, 2018 Continued Consultation documents ATC/DDD classification 229 The International Pharmacopoeia 276 ATC/DDD classification (temporary) 229 Atazanavir sulfate 279 ATC/DDD classification (final) 233 Atazanavir capsules 237 Daclatasvir dihydrochloride 245 Daclatasvir tablets International Nonproprietary 249 Polymorphism Names (INN) 255 WHO medicines quality guidelines 255 Inquiry regarding production of water for 283 Proposed INN: List 119 injections 257 Proposal for revision of the WHO Certification Scheme 275 Other recent WHO consultation documents 18th International Conference of Drug Regulatory Authorities (ICDRA) The 18th ICDRA will be hosted by the Health Products Regulatory Authority (HPRA) of Ireland and the World Health Organization Dublin, Ireland, 3–7 September 2018 http://www.icdra2018.ie/ Abbreviations and websites 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) HPRA Health Products Regulatory Authority, Ireland (www.hpra.ie) ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (www.ich.org) IGDRP International Generic Drug Regulators Programme (https://www.igdrp.com) 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) Ph. Int The International Pharmacopoeia (http://apps.who.int/phint/) PIC/S Pharmaceutical Inspection Co-operation Scheme PRAC Pharmacovigilance Risk Assessment Committee (EMA) PMDA Pharmaceuticals and Medical Devices Agency, Japan (www.pmda.go.jp/english/index.htm) Ravimiamet Estonian medicines agency, Estonia (www.ravimiamet.ee) Swissmedic Swiss Agency for Therapeutic Products (www.swissmedic.ch) TGA Therapeutic Goods Administration, Australia (www.tga.gov.au) U.S. United States of America WHO World Health Organization (www.who.int) Note: The online version of this issue (freely available at www.who.int/medicines/publications/druginformation) has direct clickable hyperlinks to the documents and websites referenced. 188 WHO Drug Information Vol. 32, No. 2, 2018 Regulatory networks Update on the WHO-National Control Laboratory Network for Biologicals WHO prequalifies vaccines for use in Member States. In 2016 WHO initiated the establishment of a Network of national control laboratories (NCLs) that test prequalified vaccines. The Network aims to reduce redundant lot release testing and contribute to more cost-effective testing, thereby improving overall regulatory oversight and reducing regulatory burden. An article about the Network was included in Issue 1 (2017) of this journal. At the end of 2017 the Network held its First General meeting, which marked the move to the operational stage. This paper provides an update on achievements and next steps. Background testing of the products. Each year they WHO prequalifies vaccines for procurement test thousands of lots against approved by UNICEF, the PAHO Revolving Fund and specifications. Once a lot has been released GAVI among others.1 Prequalified vaccines by the responsible NCL, and provided that are used to immunize approximately two it is shipped and stored under appropriate thirds of the global birth cohort each safe conditions, it can be considered to meet year.(1) A condition for acceptance of its specifications. WHO guidelines therefore prequalification applications for a vaccine is recommend that regulatory authorities that the national regulatory authority (NRA) should use risk-based testing approaches responsible for its oversight has passed a and should consider relying on the outcomes WHO assessment of defined vaccine-related of the lot release done by other regulators.(3) functions,(2) including the evaluation of An example of such reliance is the approach vaccine batches before they are released onto used in Europe, where by law each vaccine lot the market.(3) may be tested only once through the Official Testing of vaccines is complex and Control Authority Batch Release (OCABR) expensive. The NCLs responsible for before being marketed in countries of the EU lot release of prequalified vaccines have and the European Economic Area2. in-depth experience with regulatory 2 Council of Europe. Batch Release for Human Biologicals: Vaccines, blood and plasma derivatives. 1 List of prequalified vaccines available at: See: https://www.edqm.eu/en/batch-release-human- https://extranet.who.int/gavi/PQ_Web/ biologicals-vaccines-blood-and-plasma-derivatives This update is based on the report of the First General Meeting of the WHO-NNB Network, held in Noida, India, on 31 October –2 November 2017. We thank Mr Mike Ward, Coordinator, WHO Regulatory Systems Strengthening (RSS) Team, for helpful comments on the manuscript. Contact Dr Ute Rosskopf ([email protected]) for further information. 189 Regulatory networks WHO Drug Information Vol. 32, No. 2, 2018 Update on the WHO-NCL Network for Biologicals Globally however, as the number and following countries have formalized their capacity of NCLs have increased, the same participation: vaccine batches are often re-tested in • Full members (responsible for testing multiple recipient countries. This is causing of one or several prequalified vaccines): unnecessary delays in supply and sometimes Australia, Belgium, Bulgaria, Cuba, leads to rejection of lots that do actually Denmark, France, Germany, India, meet specifications, due to differences in Indonesia, Italy, Senegal, South Africa, testing methods. Switzerland, Thailand, the Netherlands and To reduce redundant testing and facilitate the United Kingdom. Agreements with access to prequalified vaccines, WHO the NCLs of Brazil, Canada, China, the therefore initiated the establishment of the Republic of Korea, Russia and Sweden were WHO National Control Laboratory Network pending signature at the time of writing. for Biologicals in 2016.3 An update on • Associate members (importing progress is provided below. prequalified vaccines): Bangladesh, Hungary and Sri Lanka. The authority Progress update of Bhutan is expected to join in the near future, and the authority of Ghana is Advocacy considering to become a Network member. The Network was discussed at the Going forward it is envisaged that regulatory 17th International Conference of Drug authorities of all WHO Member States will Regulatory Authorities (ICDRA), leading to participate in this Network, which offers a two formal recommendations: pathway for mutual recognition and reliance • (To WHO:) Establish a global network at the global level. of national vaccine control laboratories involved in testing of WHO-prequalified General Network meetings vaccines. One of the two main routes of Network • (To Member States:) For efficient lot operations is through
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