1 WHO DRUG INFORMATION V O L U M E 3 N U M B E R RECOMMENDED INN LIST 29 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION GENEVA
2 WHO Drug Information WHO Drug Information provides an overview of topics relating to drug development and regulation that are of Current relevance and importance, and will include the lists of proposed and recommended International Nonproprietary Names for Pharmaceutical Substances (INN). Its contents reflect, but do not present, WHO policies and activities and they embrace socioeconomic as well as technical matters. The objective is to bring issues that are of primary concern to drug regulators and pharmaceutical manufacturers to the attention of a wide audience of health professionals and policy-makers concerned with the rational use of drugs. In effect, the journal seeks to relate regulatory activity to therapeutic practice. It also aims to proivde an open forum for debate. Invited contributions will portray a variety of viewpoints on matters of general policy with the aim of stimulating discussion not only in these columns but wherever relevant decisions on this subject have to be taken. WHO Drug Information is published 4 times a year in English and French. Annual subscription: Sw. fr. 50. Airmail rate: Sw. fr. 60. Price per copy: Sw. fr. 15. World Health Organization 1989 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. For rights of reproduction or translation, in part or in toto, application should be made to: Chief, Office of Publications, World Health Organization, 1211 Geneva 27, Switzerland. The World Health Organization welcomes such applications. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city, or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Authors alone are responsible for views expressed in signed contributions. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature which are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. ISSN
3 Volume 3, Number 3, 1989 World Health Organization, Geneva WHO Drug Information Contents General Policy Topics WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce: Guidelines for Use Reports on Individual Drugs Rifampicin and venous thrombosis Minimizing steroid requirements in asthmatics Induced resistance to zidovudine Interferon alfa: a role in HIV infection? Dipyrimadole: a place in the management of HIV infection? Ciclosporin and atherosclerosis Is chloroquine resistance in falciparum malaria reversible? Chloramphenicol-induced aplastic anaemia: confusing evidence Carbamazepine: evidence of teratogenic potential Acetylsalicylic acid and coronary disease: benefits and risks AIDS vaccines: are the prospects improving? General Information Antibiotic-resistant pneumococci: disturbing trends Food-based oral rehydration preparations Labelling errors: GMP changes contemplated Postmenopausal hormone replacement: is there really a cancer risk? Erythromycin resistance in Streptococcus pyogenes Folate supplements and neural tube defects Contrast media: the risk of nephropathy Oral contraceptives and breast cancer Anti-leukaemic therapy: a need for tang-term assessment Bioengineering: new therapeutic perspectives Good Manufacturing Practices: a catalogue of shortcomings Exports from Europe: a turn of the screw Hypolipidaemic agents: who should receive them? Regulatory Matters Dideoxyinosine: a promising anti-hiv agent Bovine brain gangliosides: interim suspension Buprenorphine: increasing diversion Chlorofluorocarbons: limitations on use Diagnostic test for HIV infection Exifone: interim suspension Disclosure of inactive ingredients Recombinant erythropoietin (INN epoetin alfa) Radiocontrast media: labelling changes Tegafur and leukoencephalopathy Tiopronin and liver damage Advisory Notices Contact lenses: risk of keratitis Mefloquine: acute neurological reactions Human T-lymphotropic virus: screening of blood products Essential Drugs Leishmaniasis Meglumine antimoniate/sodium stibogluconate Pentamidine Amphotericin B Newly Registered Products Recent publications Scientific basis of fertility regulation: safety requirements for contraceptive steroids Medicines in pregnancy Drugs used in anaesthesia Recommended International Nonproprietary Names: List
5 WHO Drug Information Vol. 3, No. 3, 1989 General Policy Topics WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce: Guidelines for Use Provisions and objectives Pharmaceutical substances are biologically active and they share, in varying degree, a potential to induce unwanted as well as beneficial effects. The risk of serious unwanted reactions and also of therapeutic failure are accentuated when products are either substandard in quality or administered incorrectly. Manufacturers consequently need to produce and package their products in accordance with accepted norms, referred to widely as "good manufacturing practices" (GMP), and to assure their correct use by furnishing adequate reliable information to both prescribers and consumers. Various codes of GMP have been developed, both at national and at international level, to cover every aspect of the production of finished pharmaceutical products. These establish norms for the qualifications and experience of the responsible personnel, the layout and amenities of production and storage areas, sanitation, maintenance of equipment, verification of starting materials, supervision of manufacturing operations, in-process quality controls, documentation, and labelling and packaging. Implementation of these practices by the manufacturer provides assurance that each batch of every product has been made from materials of the required quality; that it complies with the labelled pharmacopoeial specification; that it is adequately packaged and labelled; and that it will remain stable and adequately bioavailable throughout its labelled shelf-life under specified storage conditions. Whereas certain governments and large independent drug procurement agencies are able to commission a full analysis of samples of each imported consignment of pharmaceutical products and active drug substances, such safeguards are beyond the resources of most countries. Still less can they verify labelled claims regarding stability and bioavailability. Even when independent analyses can be undertaken, their limitations must be appreciated. For instance, impurities irrelevant to an established pharmcopoeial monograph, but generated when a substance is produced using a novel route of synthesis, might escape detection in the prescribed analyses. A comprehensive system of quality assurance must consequently be founded, not only on a reliable system of licensing and when practicable independent analysis of the finished product, but also upon assurance, obtained through independent inspection, that all manufacturing operations are carried out in conformity with the requirements of GMP. Transnational commerce in pharmaceutical products would be greatly facilitated if all inspections were conducted in accordance with internationallyrespected standards. To provide an administrative basis for reciprocal recognition of the findings and decisions of their respective inspectorates, a number of highly-evolved national drug regulatory authorities founded the Pharmaceutical Inspection Convention under the aegis of the European Free Trade Association in Similar understandings have been developed between the Member States of the Council for Mutual Economic Assistance, and those of the Association of South-East Asian Nations. Mutual recognition is the outcome of bilateral understandings between collaborating countries. If international trade in pharmaceuticals is to be facilitated in a global context, multilateral understandings are also necessary. Thus, recognizing the need to establish norms for GMP which any Member State is free to adopt and apply, the World Health Assembly endorsed the first version of the WHO Good Manufacturing Practices Text and WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce in The Scheme, which was extensively amended in 1975, is an administrative instrument through which each participating Member State undertakes, upon application by the product licence-
6 General Policy Topics WHO Drug Information Vol. 3, No. 3, 1989 holder, to provide to the competent authority of another participating Member State an attestation on whether: a specific product is authorized for sale or distribution within the exporting Member State; and the plant in which it is produced is subject to inspections at suitabe intervals to establish that the manufacturer conforms to WHO's recommendations for GMP. In 1988, the Scheme was re-examined following recognition that more widespread and rigorous use of its provisions offers a mechanism not only of controlling legitimate trade in pharmaceutical products but of combating illicit trade in falsely labelled, counterfeited or substandard goods. It was further decided to bring within its ambit: not only finished dosage forms of products intended for human administration but, additionally: dosage forms of veterinary products administered to food-producing animals and also those starting materials that are subject to control by legislation in the exporting Member State. all approved information and/or labelling included in packaging materials and package inserts supplied with these products in the country of export, together with the dates on which relevant approvals were accorded. Eligibility for participation Any Member State intending to participate in the Scheme may do so by informing the Director- General of the World Health Organization, in writing, of: its willingness to participate in the Scheme together with any significant reservations it intends to observe relating to this participation; and the name and address of its principal competent authority, i.e., its national drug regulatory authority. These notifications are subsequently published in the monthly WHO Pharmaceutical Newsletter and also in WHO Drug Information. A Member State may opt to participate solely for the purpose of importing pharmaceutical products and substances. This intention should then be stated explicitly in its notification. A Member State intending additionally to use the Scheme in connection with the exportation of pharmaceutical products and substances must first satisfy itself that it possesses: an effective national licensing system, not only for pharmaceutical products, but also for the responsible manufacturers and distributors; GMP requirements, consonant with those recommended by WHO, to which all manufacturers of finished pharmaceutical products or licensed pharmaceutical substances are required to conform; effective controls to monitor the quality of pharmaceutical products admitted to the market, including access to an independent quality control laboratory; a national pharmaceuticals inspectorate, operating as an arm of the national drug regulatory authority, that possesses the technical competence, experience and resources to assess whether GMP and other controls are being effectively implemented, and with the powers to conduct appropriate investigations to ensure that manufacturers conform to these requirements by, for example, examining premises and records and taking samples; administrative capacity to issue the required certificates, to institute inquiries in the case of complaint, and to notify expeditiously the competent authority in any Member State known to have imported a specific product that is subsequently associated with a potentially serious quality defect or other hazard. It is for each Member State to determine, through a process of self-evaluation, whether it satisfies these prerequisites. The Scheme contains no provision, under any circumstance, for external inspection or assessment, either of a competent national authority or of a manufacturing facility.
7 WHO Drug Information Vol. 3, No. 3, 1989 General Policy Topics Scope and format of the certificate The certificate transmits information relevant to a specific pharmaceutical product. It is prepared by the competent authority in the country of export ('the certifying authority") upon application by the licenceholder (the applicant") and it is delivered to the competent authority in the importing country ("the requesting authority"). The requesting authority has the option of determining the application for importation exclusively on the basis of the certified information, or of requesting supplementary data from the applicant. The recommended format of the certificate is displayed on page 115. Each product or substance should be identified by: the name by which it is commercially designated and the dosage form; the international nonproprietary name and the amount of each active ingredient; and the name of the manufacturer and, when applicable, the agent responsible for placing the product on the market in the country of export. The attestation provided on the status of the product or substance in the country of export should indicate: whether it has been authorized to be placed on the domestic market and, if not, the reasons why such authorization is lacking; whether the manufacturing plant in which it is produced is subject to inspections at suitable intervals and, if not, the reason why such inspection is not undertaken; that the manufacturer conforms to GMP requirements, as recommended by the WHO; and that the complete text of all labelling and prescribing information authorized for use in the country of export, as submitted by the applicant, is appended to the certificate. In notifying its intention to participate in the Scheme a Member State enters into no commitment to certify supplementary information. Additional certified data, such as a disclosure of the complete qualitative and quantitative formula of the finished dosage form, are thus obtainable only at the discretion of the certifying authority and with the permission of the applicant. Other items that might be added on this basis to satisfy licensing requirements in the importing Member State include information on the date of manufacture, results of analyses, dissolution and bioavailability data, stability data, packaging, shelf-life and any approved technical summary on which the marketing authorization in the country of export is based. In the absence of any specific agreement, each certificate will be prepared exclusively in the working language(s) of the certifying authority. The applicant will be responsible for providing any notarized translation that may be required by the requesting authority. It is recognized that implementation of the Scheme imposes a significant administrative service on certifying authorities. This service may need to be financed by levying a fee on applicants. The certificate refers to products "authorized to be placed on the market" rather than to products that "are sold" in the country of export. Since the certi fying authority can attest only to matters related to its formal responsibilities. Decisions regarding the marketing of duly-licensed products are determined by the applicant. The objective is to establish whether a product licence has been granted with the explicit purpose of authorizing the applicant to place the product on the market in the country of export subject to any conditions that may be applied. Some products may not be authorized for sale in the country of export for reasons that are unconnected with considerations of quality, efficacy and safety. These include: products developed exclusively for the treatment of conditions and particularly tropical diseases not endemic in the country of export. These, when they are not intended for sale and distribution within the country of export, may fall outside the statutory purview of the certifying authority. Even when this is not the case, the certifying authority can exert no influence over the clinical or post-marketing phases of the development of a product that is not used within its jurisdiction. In these circumstances, the requesting authority has the option of turning to the World Health Organization for technical advice. However, it will need assurance from the certifying authority that GMP has been observed in all stages of the manufacture of the product.
8 General Policy Topics WHO Drug Information Vol. 3, No. 3,1989 products that have been reformulated with a view to improving their stability during storage under tropical conditions or to exclude excipients not approved for use in pharmaceutical products in the country of import. These would normally qualify for approval by the certifying authority only after technical review of the implications that the proposed changes might have for the stability and bioavailability of the product and for other aspects of its safety and efficacy, and a statement to this effect should be entered into the certificate. Each certificate is intended to convey information on one product only. This principle has become of greater moment now that exchange of product information has been brought within the ambit of the Scheme. Confusion is liable to arise if information relating to different products, or even different dosage forms, is attached to the same certificate. The approved information for different dosage forms of the same active substance frequently differs substantially particularly with reference to composition, indications and dosage instructions. Notwithstanding these considerations, importing Member States frequently issue international tenders citing large numbers of products and, in doing so, request manufacturers to support their bids with export certificates. Supplying large numbers of detailed certificates in these circumstances would impose an unacceptable administrative burden on the certifying authority and add substantially to the costs of the tendering procedure. In these circumstances, preliminary proof that a valid product licence exists within the exporting country for each of the products cited is all that is usually required. Subject to the agreement of the tendering authority, a single short-form certificate referring to several products might then be issued. As a minimum, this would identify each product in the terms described above, its licence number in the country of export, and the date on which the licence was issued. It would also provide a declaration that a separate and complete certificate for each product will be provided on request. Requesting a certificate A product certificate is a confidential document. As such, it can be prepared only in response to an application by the holder of the product licence (the applicant). An importing agent or a national drug regulatory authority requiring certified information on a product should consequently channel the request through the applicant in the exporting Member State. In the course of issuing an open tender an importing agent may also wish to place bidders on notice that certified evidence of marketing authorization in the country of export will be required as a condition of acceptance of a bid. Clear understandings must be established between the competent national authority and all agents operating under its aegis that hold responsibility for importing drugs into the country, within both the public and the private sectors, on when certificates will be required for licensing purposes. In general terms, the competent authority will require certified information whenever a licensing action is required to provide authorization to import: any product not previously licensed within the country of import, including a multisource product not licensed to be imported from the manufacturer in question. any previously licensed product when, for any reason, administrative action is required to renew, extend, vary or review the existing licence. By formally notifying its participation in the Scheme a Member State signifies its general acceptance that the assurances it provides, together with any additional collated information on the product in question it may require from the applicant, comprise a sufficient basis for it to determine whether the product may be licensed for importation and marketing within its jurisdiction. Only exceptionally should requests for supplementary information be referred to the certifying authority. It is the responsibility of the requesting authority to determine the period during which it will accept certified information as valid. It may wish to impose, as a general condition, a requirement upon the licence holder to submit an updated certificate periodically say, perhaps, at five-year intervals as a condition of extension or renewal of the product licence. The WHO Scheme additionally provides for the certification of specific batches of a product or substance covered by an existing certificate. It indicates that such certificates could be issued either by the manufacturer or by the competent authority of the exporting Member State. However, batch certification is only undertaken exceptionally by the competent national authority, and usually only in relation to vaccines and other biologicals. For other
9 WHO Drug Information Vol. 3, No. 3, 1989 General Policy Topics products, responsibility for batch certification, including assurance of compliance with pharmaco poeial or other specifications, and of the expiry date under specified storage conditions, devolves upon the applicant and the importing agent, subject to any conditions imposed by the requesting authority. The attestation regarding compliance with GMP should be provided only when the certifying authority has ascertained, to its satisfaction, which stages of the manufacturing operations are undertaken in the premises that have been subjected to inspection. The practice of purchasing multisource (i.e. generic) products or substances in response to bids received on open tender holds particular implications for the certification procedure. Whenever a product is purchased through a broker or another intermediary, or when more than one set of premises has been involved in the manufacture and packaging of a product, certified documentation should be provided from the competent authorities in each of the countries involved, variously, in the manufacture, assembly, packaging, repackaging, relabelling (to give it a new designation), or transshipment of the product, in a way that reliably establishes its "pedigree". Issuing a certificate Responsibility for the authenticity of the data contained in a certificate issued in conformity with the Scheme is assumed by the certifying authority. Certificates will not bear the emblem of the World Health Organization, but a statement should always be included to confirm that the document is issued in the format recommended by WHO. When such confirmation cannot be supplied the reasons should be stated. In general, certificates will be issued on the basis of data contained in the current version of the product licence. The certificate should accordingly indicate the date on which the information supplied was established to be correct. This will reflect the occasion on which the product licence was most recently reviewed. In particular, every effort should be made to indicate the dates on which: the manufacturing facility was last inspected; the product information was last reviewed. ft should be recognized that GMP assigns responsibility for assuring the quality of starting materials on the manufacturer of the final dosage forms. Many competent authorities, none the less, require the anticipated manufacturers of starting materials to be specified in the product licence. As a matter of policy, the competent authority may neither inspect manufacturers of starting materials nor license their products or, should it do so, it may limit such inspections to selected active ingredients. Notwithstanding this situation, a certifying authority may agree, on a discretionary and voluntary basis, and at the request of a manufacturer, to undertake an inspection of a manufacturer of starting materials to satisfy specific requirements of a requesting authority. Alternatively, the certifying authority may be able to attest that the manufacturer is an established supplier of the substance in question to manufacturers of finished dosage forms licensed for marketing under its jurisdiction. Whenever possible, international nonproprietary names, as selected by the World Health Organization, should be employed to identify active ingredients. A declaration that a product has been authorized to be placed on the market should be qualified, whenever applicable, by any restriction upon its sale, distribution or administration that is entered into the product licence. In many countries, some long-established products still remain on the market on the basis of provisional licensing arrangements. These have not been subjected to full technical assessment in accordance with contemporary statutory requirements. Certified information relating to such products should indicate clearly in what respects statutorily-required review remains pending. In certifying that the manufacturing facility is subject to inspection at suitable intervals and that the manufacturer conforms to WHO recommendations on GMP, it should be ascertained: to what extent the manufacturing facility in question has contributed to the production of the finished dosage form, including its labelling and packaging; that the inspectorate has satisfied itself that the manufacturer is implementing, in all material respects, recommendations specifically applicable to biological products that have been adopted by the WHO Expert Committee on Biological Standardization and other WHO expert groups as published in the WHO Technical Report Series;
10 General Policy Topics WHO Drug Information Vol. 3, No. 3, 1989 that the same norms are applied to the production of all batches of pharmaceutical products manufactured within the facility, including those destined exclusively for export; that the applicant consents to relevant inspection reports being released, in confidence, to the competent authority in the country of import, should the latter so require, together with the names and functions of the persons within the company designated to sign certificates of individual batches of the product to be exported, and information on any independent controls exercised by the competent authority, as a condition of marketing, on batches of the product prior to their release. In those instances in which more than one company contributes to the production of a finished dosage form the certificate should either: provide separate attestations to cover those aspects of manufacture undertaken by each of the interested parties; or identify those aspects of the manufacturing operation for which no attestation can be provided. Because of the administrative workload involved, it may not always be feasible for the certifying authority to attest that copies of information and labelling submitted to it by an applicant in support of a request for a certificate are consonant, in every particular, with the conditions of the relevant product licence. In these circumstances, the only practicable recourse for the certifying authority may be to stamp each of these documents as having been submitted to it on a given date in support of an application for a certificate. Every effort should be taken, however, to ensure, by inspection, that the information is complete, particularly in respect of indications for use, dosage instructions, precautions and contraindications. In the event of any apparent deficiency or discrepancy, certification should be held in abeyance pending clarification and satisfactory resolution of the matter by the applicant. The requesting authority should also check, as far as is practicable, that these accord with any officially-approved product information contained in published compendia used within the country of export, which are supplied to the national information officers under the aegis of WHO. Any attachment to a certificate, including dulystamped product information or price lists of products for which bids are offered, should be clearly identified as not comprising part of the attestation made by the certifying authority. To avert potential abuse of the Scheme and to enable the certifying authority to maintain comprehensive records of countries to which specific products have been exported, each certificate should identify the requesting authority, be stamped on each page with the official seal of the certifying authority and be issued directly to the requesting authority. Copies provided to applicants should bear no official seal and be clearly marked as duplicates. Notifying and investigating a quality defect Each participating Member State undertakes to institute enquiries into any quality defect reported in a product or substance exported in accordance with the provisions of the Scheme, on the understanding that: the complaint is transmitted, together with the relevant facts, through the competent authority in the country of import; the complaint is considered to be of a serious nature by the latter authority; and the defect, if it appeared after the delivery of the batch in question into the importing Member State, is not attributable to local conditions. Conversely, each certifying authority undertakes to inform the competent authorities in countries that have imported a product under the provisions of the Scheme of any serious hazards subsequently associated with its use when such a product has been distributed internationally. The certifying authority will execute this responsibility by issuing an appropriate warning to the World Health Organization of the defect, through the officially-designated information officer, for relaying to all Member States. The World Health Organization stands prepared to offer advice and particularly to identify a quality control laboratory disposed to undertake independent analytical tests should difficulty arise in resolving a complaint, but it cannot engage in any consequential litigation or arbitration.
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