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FOOD AND DRUGS AUTHORITY GHANA

Regional Center of Regulatory Excellence in Clinical Trials, Drug Registration and Pharmacovigilance
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BLOOD REGULATION IN GHANA

Blood and its derivatives are life-saving therapies for countless trauma cases; including accidents, burns, surgery, haemorrhage during labour, delivery, and postpartum as well as treatment for certain cancers and diseases. The World Health Organization (WHO) estimates that 26 per cent of maternal deaths in sub-Saharan Africa, including Ghana, are directly related to the lack of Quality and Safe blood and blood products. It is therefore imperative that the FDA initiates the regulation of whole blood and its derivatives along the entire transfusion chain in consonance with the concept of Whole Blood and its derivatives as ESSENTIAL MEDICINES - unanimously endorsed by the WHO Expert Committee on Biological Standardization (ECBS), the WHO Blood Regulators Network (BRN) and the International Conference of Drug Regulatory Authorities (ICDRA) in October 2012

In resolution WHA63.12, the World Health Assembly (WHA) recognized that stringent regulatory control is vital in assuring the Quality and Safety of Blood and its derivatives and edged member states to update their national legislation to meet internationally recognized standards. In Ghana, the FDA is encouraged by the Public Health Act 2012 (Act 851) to pursue its mandate of protecting public health and safety through the licensure of Blood Facilities (BF) and the listing of blood products manufactured in those facilities.

Who is going to be regulated?

BF that:

· conduct donor screening

· collect blood and blood components

· conduct testing for Transfusion Transmissible Agents

· process whole blood into blood components and blood products

· store blood, blood components and blood products

· release and distribute blood, blood component and blood products

· conduct compatibility testing on blood and blood components

· carry out secondary processing of blood components such as;

· Irradiation/Cell wash/Pack splitting

· BF that collect blood and/or blood components for pre-deposit autologous transfusion

NOTE: If a facility receive blood and/or blood components from another facility for transfusion purposes but do not perform compatibility tests on site, that facility shall not be classified as a Blood Facility

The FDA Shall:

· Allocate a site number to all Blood Facilities

· Issue a license for regulated Blood Facilities

· List all articles, including whole blood and blood derivatives manufactured in licensed Blood Facilities

· Inspect Blood Facilities twice in a year

· Actively monitor the system for reporting Serious Adverse Blood Reactions or Event (HAEMOVIGILANCE/SABRE)

· Implement periodic training programmes for staff and management of Blood Facilities

THE BLOOD FACILITY SHALL:

· Pay an administrative fee towards Blood Facility licensure

· Comply with all the conditions necessary to maintain the license status

 

GUIDANCE DOCUMENT FOR BLOOD FACILITY LICENSURE APPLICATION FORM click for more

GUIDELINES FOR LICENSING BLOOD FACILITIES AND BLOOD PRODUCTS LISTING click for more

APPLICATION FORM FOR BLOOD FACILITY PRODUCTS LISTING IN GHANA click for more

APPLICATION FORM FOR LICENSING BLOOD FACILITIES IN GHANA click for more

 

 

 

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