DRUG REGISTRATION AND INSPECTORATE DIVISION

Drug Evaluation and Registration Department

The Drug Evaluation and Registration Department is responsible for the evaluation of medicine registration applications leading to the registration of medical products. Some of the achievements of the department are detailed below.

  • A system of registration of medicinal products has been established over the past 16 years and is well controlled to ensure consistency of activities and regulatory decisions on all medicine registration applications.
  • The department has competent dossier evaluation committee that reviews all parts of dossiers submitted for registration. Two of the assessors are currently members of the WHO Prequalification Assessment Team. The department is currently contributing to the WAHO harmonization process.
  • The department has a detailed guideline to control the names of products, information on product characteristics and patient information leaflet. This is strictly controlled to ensure that information on product to health professionals and patients are not deceptive. Product brand names and colour schemes are also controlled to avoid prescription errors.
  • The department has a system to ensure the monitoring of applications after registrations. Including tracking of variations to registration applications.

 

Herbal Medicine Department

The Herbal Medicine department is responsible for the evaluation of herbal medicine and food supplement registration applications leading to the registration of herbal medicines in Ghana. Some of the achievements of the department are detailed below:

  • Improvement in packaging of herbal medicinal products sold in medicine sales outlets.
  • Enforcement of manufacture of herbal medicinal products from designated facilities with basic GMP for herbal medicine facilities.
  • Trained over 300 herbal medicine manufacturers and traditional medicine practitioners engaged in extemporaneous preparations in GMP and registration requirements.
  • Trained officers of National Drug Regulatory Authorities from some African countries on establishing a regulatory framework for Herbal medicine regulation.

 

Drug Enforcement Department

The Drug Enforcement Department is responsible for ensuring quality assurance of manufacturing and warehouse facilities. The department also carries out post market surveillance activities on regulated products. Some of the achievements of the department is detailed below:

  • Improvement in the quality of anti-malaria on the Ghanaian market through constant monitoring resulting in steady decline in the incidence of substandard, spurious, falsified, falsely labeled and counterfeit anti malarias as shown in the table below.

 

Year

Estimated % of SSFFC  anti-malarias

2008

39%

2009

22%

2010

17%

2011

11%

2012

6%

 

  • Improvement in general enforcement activities resulting in the reduction of SSFFC medicinal products in the market.
  • The department currently exercises oversight responsibility on 38 local pharmaceutical manufacturing companies in the country.
  • Training of the local industry on various aspects of GMP, GDP and GLP.
  • Increase public awareness of the activities of the FDA.

 

Tobacco and Substance of Abuse Department

The Tobacco and Substance of Abuse Department is responsible for the regulation of Tobacco and Tobacco products as well as the regulation of licit narcotics, psychotropic substances and precursor chemicals. Some of the achievements of the department is detailed below:

  • Enforcement of the provisions of the Tobacco Control measures has led to the control of advertisement, promotion and sponsorship of tobacco products as well reduction of smoking in public places.
  • The department’s educational activities have led to the reduction of smoking in public places.
  • Enforcement of the provisions of the international conventions on psychotropic and narcotic substances leading to the restriction of use of narcotics and psychotropic substances for only research and medicinal purposes
  • Enforcement of the provisions of the international drug conventions on narcotics, psychotropic substances and precursor chemicals has led to the restriction of the use of these controlled substances for only medical and scientific purposes whilst preventing diversion into illicit trade and abuse

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