Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Fermer ce répertoireANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Fermer ce répertoireA. IMPORTING COUNTRIES
Afficher le documentBenin
Afficher le documentCameroon
Afficher le documentCentral African Republic
Afficher le documentEcuador
Afficher le documentFiji
Afficher le documentJamaica
Afficher le documentKenya
Afficher le documentMalawi
Afficher le documentMalaysia
Afficher le documentMyanmar
Afficher le documentPapua New Guinea
Afficher le documentSri Lanka
Afficher le documentTanzania
Afficher le documentTunisia
Afficher le documentYemen
Ouvrir ce répertoire et afficher son contenuB. EXPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenuC. INTERNATIONAL SUPPLY AGENCIES
Afficher le documentBACK COVER
 

Malaysia

1. Population

18 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 150 million. Main suppliers were: Australia, France, Germany, Italy, Sweden, UK and USA.

Drug consumption in 1992 in the public and private sector amounted to US$ 48 and US$ 172 million respectively. The estimated public sector drug budget for 1992 was US$ 49 million and the national contribution was 100%.

3. Drug policy and essential drugs list

There is no written and approved national drug policy as such but elements relating to drug regulatory control, drug registration, drug procurement are being practised.

A drugs list developed on 14 May 1983 is being used for procurement in the public sector. The list comprises 1116 products (670 chemical entities). The list is regularly updated following the decisions of the Drug Review Panel at the Ministry of Health, which meets every six months.

4. Infrastructure and functioning

4.1 Drug regulation and registration

The National Pharmaceutical Control Bureau (NPCB) of the Department of Pharmaceutical Services is responsible for drug regulation and registration. Drug regulation is governed by the Sale of Drugs Act of 1952 (revised 1989) and the Drugs and Cosmetics Control Regulations 1984. The Drug Control Authority is responsible for drug registration and consists of ten members appointed by the Ministry of Health. The technical work necessary for drug registration is done by the National Pharmaceutical Control Bureau. Drug registration started in 1985 and the procedure was subsequently modified to its present form in 1992.

Registration documents issued since 1992 specify a five year validity period for registration. The total number of products registered at the beginning of 1993 was 9792, including 5910 prescription only products and 3882 non prescription products. As a matter of policy, only products authorized in the country of origin are accepted. Similarly, only registered products can be imported into the country.

4.2 Public and private procurement

The Government Pharmaceutical Laboratories and Stores (GPLS) procures drugs centrally for the public sector and procurement is done by means of open tender. In 1992, about 347 products were bought from wholesalers through local tendering agents.

In the private sector there are 107 drug importing companies and 315 drug wholesalers. 80% of the drug consumption in Malaysia is provided by the private sector. There are 14 wholesalers importing and distributing drugs for the private sector. In 1992, drugs were also purchased by the private sector from Austria, France, Germany, Italy, Sweden, UK and USA.

4.3 Quality control of drugs

Quality control of drugs purchased by GPLS has been carried out since 1991 by a random selection of items. In 1992, 320 samples of pharmaceutical products received by GPLS were tested, out of which 132 samples (14%) failed the tests. In addition, 132 samples of raw materials were tested in connection with tender offers. Samples are collected at the time of bidding for raw materials; and after receipt but before payment and following complaints for finished dosage forms. Analysis of samples is done locally by the quality control laboratory of GPLS and at the National Pharmaceutical Control Bureau.

Drugs imported by the private sector are not tested by importers. Importers are requiring batch analytical certificates from manufacturers abroad which they file without reviewing them against specifications. The regulatory authorities, on the other hand, subject products imported by the private sector to quality control testing under the Post Registration Market Surveillance Programme. In 1992, some 900 samples of imported and locally manufactured products were analyzed under the programme.

4.5 Inspection

There are pharmacy inspectors in each state who inspect pharmacies, importers and manufacturers.

 


5. Operation of the WHO Certification Scheme

Malaysia accepted the Scheme on 16 April 1982. The responsible authority is the Secretary, Drug Control Authority, National Pharmaceutical Control Bureau, Jalan University, P.O. Box 319, 46730 Petaling, Jaya. The name and address of the authority is included in the last issue of the WHO Secretariat list.

The receipt of a Certificate of a Pharmaceutical Product as well as a GMP certificate is a prerequisite for drug registration in Malaysia. The requirement is formally laid down in guidelines for registration of pharmaceutical products. Since 1985, these requirements have been generally adhered to. In 1992, the percentage of product license applications received for which a Certificate of a Pharmaceutical Product was provided by the applicant either as a single certificate or as two separate certificates, Free Sale and GMP, was 100%. Contact with the competent authorities is made directly. Sometimes certificates are rejected because of non compliance with the WHO 1975 format/content and because of lack of signatures/designations of the certifying authority.

Drugs imported by the public and private sector are registered and in addition batch analytical certificates are required to accompany each batch of biological products and blood products that are imported by the public and private sectors. In the private sector certificates are filed by importers for presentation to pharmaceutical inspectors.

Contact with competent authorities is through importers and manufacturers. Information on drugs registered in the country is communicated to relevant institutions through an updated list of registered products against payment of a fee. Current printouts of the list are distributed twice a year to enforcement officers and public sector procurement authorities.

Observations:

• Certificates of a Pharmaceutical Product are issued sometimes by local authorities that are neither indicated in the WHO list nor known to be officially empowered to issue certificates.

• Certificates are frequently not available for products manufactured under contract for use outside the country of manufacture.

• Certificates are not obtained for products that are not regulated in the country of manufacture.

• Batch certificates make no reference to the relevant Certificate of a Pharmaceutical Product issued by the regulatory authorities in the exporting country.

• There is no feedback to regulatory authorities in the exporting countries on products that have failed quality control tests.

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