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
 

Ecuador

1. Population

10 million in 1992.

2. Pharmaceutical import and consumption

Total imports of pharmaceuticals in 1992 were estimated to be US$ 140.1 million. The major exporting countries were Germany 25%, Spain 7%, Switzerland 8% and USA 59%. The consumption of drugs in the public and private sector in 1992 amounted to US$ 2.5 and US$ 150.1 million respectively. The total drug budget for the public sector in 1992 was US$ 3.4 million.

3. Drug policy and essential drugs list

Ecuador's national drug policy is stipulated in the Executive Order 2007, Official Register No. 570, dated 26 November 1990. The document encompasses general guidance regarding pharmaceutical production, supply, regulatory control, dispensing and policies related to medical assistance programme.

There is an essential drugs list called " National Essential Drugs List" developed in 1992. The list comprises 438 substances and is being used for procurement in the private sector.

4. Infrastructure and functioning

4.1 Regulation and registration

Drug registration and regulatory activities are described in the Code of Health, Official Register No. 158, 1971, and the Regulation for Medications, Cosmetics and Hygiene Products, Ministry Accord 8022, Official Register No. 391, dated 1 August 1977. The majority of Ecuador's drug laws and regulations are currently under revision due to the complexity of the administrative process and the lack of adequate resources and trained personnel. Among the changes planned are the rewriting of the February 1971 Code of Health and the adoption of a new Medications Law, incorporating supply and regulatory concerns. The latter was drafted by the National Health Board and is currently under review by the Ministry of Public Health.

Registration of drugs in Ecuador is primarily an administrative procedure whereby applicants are legally required to present samples of pharmaceutical products for analysis by the National Institute of Hygiene and Tropical Medicine. Registration of drugs was introduced in 1971 and the percentage of drugs registered at the time of the mission was 98%.

The Cooperative Programme between Ecuador, WHO, PAHO and the Netherlands, has contributed to the development of computerized registration systems. The government has also begun to implement a programme for generic drugs that provides special procedures for the procurement, control and registration of this category of drugs.

4.2 Public and private procurement

In the public sector procurement is done by the Centro Estatal de Medicamentos e Insumos Médicos (CEMEIM). It distributes to all public health institutions, to include hospitals, health centres, official pharmacies, etc.

The Ecuadorian Social Security Institute purchases pharmaceuticals for its direct affiliates, employing a basic drugs list different from the National Essential Drugs List.

In the public sector procurement is done by means of open tender and direct purchase from manufacturers/agents and international supply agencies. In 1992, about 110 products were purchased from manufacturers/agents. Drugs were also obtained from UNICEF during the same year.

In the private sector drugs are procured directly from wholesalers abroad. The main suppliers in 1992 were Germany, Spain, Switzerland and USA.

4.3 Quality control of drugs

The National Institute of Hygiene and Tropical Medicines Estate Laboratory, Guayaquil tests the quality of drugs. In 1992, 36 samples were sent for testing and 75% passed the tests. Samples are usually sent for testing after receipt of drugs but before payment and following complaints. Quality control of drugs during procurement is limited due to shortage of adequate laboratory facilities and lack of clear public policies within the respective organizations.

Drugs imported by private sector are tested on a small scale only. In 1992, samples of 18 products were analyzed and nine samples failed.

4.4 Inspection


The Direction Nacional de Control Sanitarios under the Ministry of Public Health is responsible for inspection.

 


5. Operation of the WHO Certification Scheme

Ecuador accepted the WHO Certification Scheme in 1985 and the competent authority is the Dirección General de Salud Públicà, Ministerio de Salud, Juan Larrea 444, Quito.

The receipt of a Certificate of a Pharmaceutical Product is not a prerequisite for drug registration. But a Free Sale certificate is requested. Certificates lacked information regarding periodic inspections, product information and labelling. The majority of the certificates reviewed during the assessment were found to have been issued by health officials from city, state and provincial governments. Drug importers, distributors and manufacturers had a vague understanding of the Scheme during the assessment.

In the public sector tenders administered by CEMEIM, participants can only offer pharmaceuticals that have previously been registered in Ecuador. Companies are also required to present copies of the Free Sale certificates that were issued when the products were initially registered.

Observations:

• The WHO Certification Scheme is not properly utilized.

• Private sector importers, distributors and exporters have very little knowledge regarding the Scheme.

• Information is not provided regarding labelling and therapeutic indications.

• Ecuador currently lacks the capability to issue export certificates that attest to GMP compliance of local pharmaceutical plants.

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