Cameroon
Official Name: Republic of Cameroon
Capital: Yaounde
Independence Day: 1 January 1960
Currency: CFA franc (XAF)
Indicators
Regulatory Authority
The National Pharmaceutical Regulatory Authority is the overarching Medicine Regulatory Authority (NPRA) in Cameroon. However, it has 5 actors that work collaboratively to complete the significant objectives of the NPRA. These actors include:
· The Department of Pharmacy, Drugs and Laboratories (DPML)
· The General Inspectorate of Pharmaceutical Services and Laboratories (IGSPL)
· The National Laboratory for the Quality Control of Drugs and Expertise (LANACOME)
· National Central Supply of Medicines and Essential Consumables (CENAME)
· The Division of Operational Research in Health (DROS)
The DPML is considered as the heart of pharmaceutical regulations in Cameroon and is one of the central technical divisions of the Ministry of Public Health (DPML, n.d.). DPML under the 2013 Act on the organization of the Ministry of Public Health charges the DPML to develop and monitor the implementation of the national policy for the supply of pharmaceutical products including medical devices, collect and disseminate pharmaceutical information, among others.
· The Department of Pharmacy, Drugs and Laboratories (DPML)
· The General Inspectorate of Pharmaceutical Services and Laboratories (IGSPL)
· The National Laboratory for the Quality Control of Drugs and Expertise (LANACOME)
· National Central Supply of Medicines and Essential Consumables (CENAME)
· The Division of Operational Research in Health (DROS)
The DPML is considered as the heart of pharmaceutical regulations in Cameroon and is one of the central technical divisions of the Ministry of Public Health (DPML, n.d.). DPML under the 2013 Act on the organization of the Ministry of Public Health charges the DPML to develop and monitor the implementation of the national policy for the supply of pharmaceutical products including medical devices, collect and disseminate pharmaceutical information, among others.
Product Registration Module
The National Medicines Commission oversees the assessment of applications for the approval of pharmaceutical products to be placed on the market. The various forms and guidelines needed for registrations can be downloaded from the DPML website (DPML, 2020). The technologies or software used in this process is not provided.
Inspections Module for both GDP and GMP
Regulatory inspections on GDP and GMP are done in Cameroon. The IGSPL usually does this. Inspectors are mandated by the law to inspect the premises where pharmaceutical activities take place, whether in public or private establishments. Inspections are legal obligations by the government that are done at least once in a year (Angwafo, 2011). There is no information on the technologies used for regulatory inspections.
Laboratory Information Management System
Cameroon has a Biological and medical analysis laboratories database. However, information on the database is currently not available. There is also a logistics information management system that is being developed to have the logistical data they need to effectively manage the health product supply chain (DPML, 2020b).
Pharmacovigilance
Cameroon has a national pharmacovigilance system. The main aim of this system to protect the safety of all citizens in the use of health products. The system would also help detect possible adverse drug reactions early. These reactions could occur under the use of health products in normal conditions, abuse, misuse, poor quality of the product, among others.
The national pharmacovigilance system consists of the national pharmacovigilance commission, the pharmacovigilance centre and the pharmacovigilance technical committee (Ministère de la Sante Publique, 2018). A citizen, patient or health worker can report an adverse drug reaction. The reporter can either download a from the DPML website or Report using the online form available on the website (DPML, 2020a).
The national pharmacovigilance system consists of the national pharmacovigilance commission, the pharmacovigilance centre and the pharmacovigilance technical committee (Ministère de la Sante Publique, 2018). A citizen, patient or health worker can report an adverse drug reaction. The reporter can either download a from the DPML website or Report using the online form available on the website (DPML, 2020a).
Clinical Trials
Clinical trials are conducted in Cameroon; however, a study needs to be authorized by the Pharmaceutical Authority before it can the study can be initiated. The investigator must apply for a review which is overseen by a committee of ethics or an institutional review board (Angwafo, 2011).
Post Marketing Surveillance
Cameroon performs post-market surveillance studiesto monitor and assess pharmaceutical products that are authorized on the market (Angwafo, 2011).
Import and Export
There is little information on the exportation of drugs. Regarding importation, regulations provided are focused on the authorization of imports for psychotropic substances, narcotic drugs, dermocorticoids and chemical precursors. Only drugs approved in Cameroon are subject to an Official Import Authorization (AOI) Request.
An Official Import Authorization form can be acquired from the Office of Standards and Pharmaceutical Legislation at the DPML premises. The application goes through a verification process. The Official Import Authorization forms are processed and signed by the Minister of Public Health before it is discharged at the Office of Standards and Pharmaceutical Legislation. Information on systems used for this process is not available.
An Official Import Authorization form can be acquired from the Office of Standards and Pharmaceutical Legislation at the DPML premises. The application goes through a verification process. The Official Import Authorization forms are processed and signed by the Minister of Public Health before it is discharged at the Office of Standards and Pharmaceutical Legislation. Information on systems used for this process is not available.
Licensure – Professionals and Premises
The DPML licenses pharmaceutical establishments and professionals to discharge their duties, respectively. There is no information on the availability of a system or portal with regards to licensing. To gain a license to operate as a pharmaceutical establishment or operate as a pharmaceutical professional in Cameroon, the applicant must first meet the indicated requirements in the guidelines.
The applicant must then complete the necessary forms, which are available on the website together with the necessary supporting documents. These must be submitted to the DPML for screening and evaluation. Upon evaluation and consideration, the application would then be approved, and a certificate would be given to the applicant.
The applicant must then complete the necessary forms, which are available on the website together with the necessary supporting documents. These must be submitted to the DPML for screening and evaluation. Upon evaluation and consideration, the application would then be approved, and a certificate would be given to the applicant.
Monitoring and Evaluation
According to Angwafo, 2011, the authority performs monitoring and evaluation (Angwafo,2011). However, there is no information regarding the processes and activities involved in monitoring and evaluation.
Track and Trace Module
According to the procedure manual for standard management drug operations in Cameroon, stock cards are used to track the movement of pharmaceutical products in the supply chain. The movements mainly involve the arrival and departure from a point—for example, manufacturer, wholesale or distribution. Drug stock managers are responsible for updating the stocks available regularly. However, there is no indication of a system which is used in this process.