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Sao-Tome-and-Principe Sao Tome principe

Official Name: Democratic Republic of Sao Tome and Principe
Capital: Sao Tome
Independence Day: 12 July 1975
Currency: Dobra (STD)

  • Indicators

Indicators

Regulatory Authority

The Central Supply of Medicines (Central de Aprovisionamento de Medicamentos) (CAME) is an institution under the Ministry of Health to supply the Sao Tomean market with medicines and hospital consumables. The CAME in connection with the National Medicines Fund (Fundo Nacional de Medicamentos) (FNM), a semi-autonomous governmental organization, is responsible for procuring, stocking and distributing essential medicines for the public sector on behalf of Ministry of Health (Ministry of Health of STP, n.d.-b).

Product Registration Module

According to a survey conducted in by “WHO and The Global Fund”, Sao Tome and Principe does not have a pharmaceutical policy, but this does not include product registration (WHO & Global Fund, 2010). The technologies used in this process are not known.

Module for both GDP and GMP

The Ministry of Health has a General Health Inspection Office (Gabinete de Inspeção Geral de Saúde) (IGAS). This office inspects, audits, controls, and evaluates the actions of health-related establishments in Sao Tome and Principe (Ministry of Health of STP, n.d.-a). Subdivisions of this office include Inspection and Licensing Commission, Medicines Control and Inspection Commission.
The IGAS ensures that all health-related establishments are in strict compliance with the law, regulations and procedures set out by the Ministry of Health. Inspections are carried out in both private and public healthcare units. Failure of the health establishment to comply with the set standard attracts a penalty. (Ministry of Health of STP, n.d.-a) There is no indication of the use of any software to carry out inspection processes.

Pharmacovigilance

Per the conducted survey, Sao Tome and Principe, does not have a pharmacovigilance centre. There is also no adverse drug reaction form for reporting (WHO & Global Fund, 2010). The information available does not include improvements in pharmacovigilance in the country. There is also no information on the technologies used in this sector.

Clinical Trials

According to the national assembly basic health law, “clinical trials are performed under medical direction per rules defined in a specific diploma and patient consent” (Ministério da Saúde de STP, 2019). However, information on the processes undertaken and the technologies used are not available.

Post Marketing Surveillance

Based on the information gathered from a survey conducted, post-market surveillance is not conducted in Sao Tome and Principe (WHO & Global Fund, 2010).

Import and Export

All medicines in Sao Tome and Principe are imported (Martinho do Rosário, 2008). As of 2007, drugs are procured through the International Dispensary Association (IDA). The IDA ensures quality, though prices are low (Martinho do Rosário, 2008).

Licensure – Professionals and Premises

According to established regulations in Sao Tome and Principe, a pharmaceutical establishment has to be owned by a licensed pharmacist for an operating license to be issued (Martinho do Rosário, 2008). However, the processes involved and the technologies used in gaining a license are not provided.

Monitoring and Evaluation

Martinho do Rosário indicated that there are no regulations regarding the monitoring and evaluation of the pharmaceutical sector (Martinho do Rosário, 2008).

Finance Module

There is no information regarding financing and payment of regulatory services. It is indicated that the regulatory authority is not financed by the payment of regulated services (WHO & Global Fund, 2010).

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