WHO Drug Information Vol

WHO Drug Information Vol. 25, No. 4, 2011 WHO Drug Information Contents Regulatory Focus Romiplostim: acute myelogenous Seven years of EU pharmaceutical leukaemia 366 regulation in Malta 343 International Pharmaceutical Federation: pharmacovigilance International Harmonization seminar in India 366 Integration and application of equivalent regulatory assessments Regulatory Action and News from other countries 354 Recommended composition of influenza vaccines: 2012 Safety and Efficacy Issues southern hemisphere 369 Asenapine maleate: serious Aprotinin: resumed marketing 369 allergic reactions 358 First ever PUMA for buccal Lenalidomide: positive benefit-risk midazolam 369 balance 358 Fidaxomicin approved for Citalopram: dose-related cardiac Clostridium difficile infection 370 risk 358 Dronedarone: restricted use 370 Terpenic derivatives: new contra- Voclosporin: withdrawal of market- indications 359 ing authorization application 370 Gonadotropin-releasing hormone: Lacosamide syrup: change in cardiovascular risk 359 formulation 371 Uromitexan: infant fatal gasping New database of European syndrome 359 experts 371 Dasatinib: pulmonary arterial hypertension 360 Consultation Documents Drospirenone: increased risk of The International Pharmacopoeia blood clots 360 Bulk density and tapped density Ondansetron: QT prolongation 361 of powders 374 TNFα blockers: Legionella and Tablet friability 378 Listeria 362 Test for bacterial endotoxins 380 Neonates exposed to antipsychotic Test for sterility 391 drugs: withdrawal symptoms 363 Chewable albendazole tablets 400 Strontium ranelate: cardiovascular Artenimol 403 and cutaneous toxicity 364 Medroxyprogesterone injection 406 Bevacizumab: ovarian failure 364 Ritonavir tablets 409 Gadolinium: nephrogenic systemic fibrosis 365 International Nonproprietary Orlistat-containing medicines Names under review 365 Proposed List No. 106 413 341 WHO Drug Information Vol. 25, No. 4, 2011 WHO Drug Information & digital library are available online at: http://www.who.int/druginformation 342 WHO Drug Information Vol. 25, No. 4, 2011 Regulatory Focus Seven years of EU pharmaceutical regulation in Malta* In an era of globalization, governments are expected to provide safety and welfare for citizens while ensuring a level playing field and boosting competitiveness for businesses. Public authorities regulate in the public interest to protect health, ensure patient access to safe medicines, stimulate innovation, encourage a competitive market, and preserve the environment (1). Malta is an island in the south of Europe with a population of 417 608 (2010). The country became a Member State of the European Union (EU) on 1 May 2004, when a total of 10 European countries joined the EU. During the process of Malta’s preparation for accession to the EU, the country transposed European pharmaceutical legislation into national legislation, leading to publication of the Medicines Act and subsidiary legislation. This established the Licensing Authority — a function which is vested in the Superintendent of Public Health — and the Medicines Authority (2). The mission of the Medicines Authority is the protection of public health in Malta through the regulation of medicinal products and pharmaceutical activities. The Authority is committed to being an effective and supportive regulator with loyalty towards its core values: protection of public health as the purpose of regulation; public trust through an impartial, consistent, disciplined and transparent approach; excellence through competent personnel with integrity, which is based on cus- tomer focused, robust, resilient and secure processes and infrastructure. Pharmaceutical regulatory patients make informed decisions on framework the choice and use of medicines. • Supporting innovation and competitive- The main objectives of medicines regula- ness through effective, efficient, pro- tion can be defined as: portionate and consistent regulation • Ensuring that only medicines of good and provision of excellent scientific and quality and favourable benefit/risk pro- regulatory advice. file are authorized and available. Pharmaceutical regulation supports • Optimizing timely, equitable and afford- the various components of a national able access to essential medicines. pharmaceutical policy, mainly research and development, authorization, produc- • Enhancing the safe and rational use of tion, distribution and use of medicinal medicines through independent infor- products. The tangible public health mation which helps prescribers and outcomes of these processes result in *Article by Patricia Vella Bonanno, CEO, Medicines Authority, and Gavril Flores, Operations and Regulatory Affairs Manager, Medicines Authority, Malta 343 Regulatory Focus WHO Drug Information Vol. 25, No. 4, 2011 Figure 1. Model of the pharmaceutical framework (3) Resources Activities Outputs Stakehoders Outcomes of the process Access Avilability Affordability & efficacy safety Quality, Rational use Structural & Legislation Human Marketing EU/national R&D, registration, √ √ √ √ √ authorization safety Patients holders Regulatory EU/national Registration, authorities safety, √ √ √ √ √ enforcement Public health Consumers Pricing EU/national Setting of price √ authorities & profit Reimbursement EU/national Establishment of Free movement Healthcare √ √ authorities reimbursement list of goods professionals Manufacturers EU/national Manufacturing/ √ √ √ & importers distribution Wholesale EU/national Distribution Open Pharmacies √ √ √ dealers competition Pharmacies National Distribution Wholesale √ √ √ dealers Healthcare EU/national Prescribing/ A true Manufacturers & √ √ professionals dispensing/ single importers administration market Patient/ EU/national Administration √ √ consumer access, availability and affordability of empowerment of healthcare professionals medicinal products which are of good and consumers (4). quality, and safe and efficacious when used rationally (Figure 1). The rational use of medicines ensures that patients receive medicines appro- Medicinal products are not always avai- priate to their clinical needs in doses that lable on the market. Affordable prices meet their individual requirements for an are an important prerequisite to ensuring adequate period of time at an affordable access to essential medicines in the cost. Continuous education of healthcare public and private sectors. Affordability is providers, patients and consumers, and influenced through promotion of compe- independent and unbiased medicines tition, through policies that encourage information empower and support deci- the use of generic medicinal products, sion making to enhance health outcomes. alternative and therapeutic substitution, Regulatory and managerial strategies good procurement practices and regula- should help to optimize safe and rational tion/control and information on prices and use of medicines and to minimize any 344 WHO Drug Information Vol. 25, No. 4, 2011 Regulatory Focus interventions which negatively impact on Within the EU regulatory framework, a rational medicines use (4). medicinal product is authorized following evaluation to ensure that it has a positive Medicines regulation within EU benefit to risk balance: that is, the product The principles of medicines regulation in should be of good quality, efficacious and the EU support public health, the free mo- safe. In these evaluations, the products vement of goods and people, compliance are assessed to ensure that the recom- with legal requirements and the concepts mended indications and any user safety of harmfulness and therapeutic efficacy. restrictions are evidence based, that The essential aim of any rules governing generic products are bio-equivalent to these areas is to additionally safeguard the reference product, that labels, patient public health through a framework which information leaflets and packaging are does not stifle the deveopment of the appropriate and patient-friendly and that pharmaceutical industry, innovation, information for health care professionals investment or trade in medicinal products (the summary of product characteristics) within the community (5). reflects authorized information. During this process, products are also assessed EU legislation is implemented on a natio- for aspects related to quality, expiry date nal level through Directives which are and recommendations for storage condi- transposed into national legislation, while tions, etc. Medicinal products are classi- Regulations are implemented in full. fied either as prescription-only medicines (POM) or over-the-counter (OTC). Figure 2. Framework for medicines regulation within EU (6) Pharmacists Policy makers Wholesale dealers Healthcare professionals National Stakeholders Importers Patient & patient organizations Manufacturers Consumers Public Health Competition National EU Pharmaceutical Legislation Legislation Rational Medicines medicine use regulation National Supply medicines policy systems Essential Medicines Research medicines Policy Human Medicines resources financing Legislation Marketing and Affordability evaluation 345 Regulatory Focus WHO Drug Information Vol. 25, No. 4, 2011 A medicinal product can only be placed Pharmaceutical regulation on the market if the marketing authoriza- in Malta tion holder submits an application for the product to be registered in that Member Optimizing access to good quality, State. Medicines in certain categories are efficacious and safe medicines authorized through a single marketing Until 2002, the procedure

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