Table 2. Analytical framework–Description of regulatory components and functions.

Analytic Categories	Description	Importance
1. Medicines Regulatory Framework	Set of policies, laws and regulations of medicines in the country	• Provides the legal basis and mandate for enforcement of regulation. • Defines the boundaries and domains to be regulated. • Defines the form and structure of the institution responsible for medicines regulation. • Provision of fee and charges to facilitate regulatory enforcement.
2. Medicines Regulatory Capacity	Includes the physical, organizational, and management structures required for adequate regulation of medicines	• It’s a vehicle for the translation of regulation goals into actual results. • Determines effectiveness and efficiency of regulation. • Establishes, provides and control resources needed for regulation.
3. Medicines Regulatory Functions  a. Medicines registration and marketing authorization	The process of evaluating medicines for quality, safety and efficacy and granting approvals for distribution in the country	• Determines the types and number of medicines that can be legally used in the country.
b. Premises licensing	Aims to control participation of important stakeholders in various aspects of the pharmaceutical supply chain.	• Maintains high quality standards by ensuring only qualified premises are allowed for manufacturing, transport, storage and selling of medicines
c. Regulatory inspection	Systems and processes that enable continuous monitoring and enforcement of compliance with established standards.	• Establish level of compliance to regulatory standards
d. Vigilance	Systems for continuous monitoring of medicines safety	• Monitor, detect, collect, assess, reporting and taking regulatory actions
e. Laboratory access and testing	Assessment and continued monitoring of medicines quality using established laboratory methods.	• Provides reliable information on the quality of medicines on the market. • Establish level of compliance to regulatory standards • Fosters evidence-based decision making.
f. Market surveillance and control	Regulation of the content, channels, and methods used to disseminate information about medicines, medical devices, and medical products. It also includes Post marketing surveillance of quality of products	• Essential in combating substandard and falsified medicines. • Protects the public from harmful and misleading information about medicines
g. Clinical trials oversight	Regulation of all aspects of clinical trials involving new and existing medicines	• Protects the rights of the trial participants. • Ensures that trials follow the appropriate ethical and scientific procedures. • Establish level of compliance to regulatory standards