The Liberian Medicines and Health Products Regulatory Authority (LMHRA) is the body that regulates pharmaceuticals in conjunction with the Pharmacy Department of the Ministry of Health in Liberia. The LMHRA is an autonomous government agency. The regulatory functions undertaken by the LMHRA are marketing authorization/registration, inspection, licensing, market and quality control, pharmacovigilance, control of clinical trials, import control and promotion and advertising of medicines (World Health Organization, 2011).

All pharmaceuticals on the Liberian market are required by law to be registered. An application can be made for an unregistered drug, a variation of a drug that has already been registered or for a re-registration of a product. The Authority, however, grants waivers to NGOs and FBOs to import medicines into the country. The LMHRA is currently working on their Marketing Authorization Portal, which would be found on their website. The NMRA is involved in collaboration and harmonization initiatives in West Africa.
For products that are registered by the West Africa health Organization (WAHO) for region wide use, the LMHRA shall cause it to be registered upon receipt of summary decision by WAHO and the payment of the applicable fees by the applicant. Applications submitted for registration in the WAHO Common Technical Document (CTD) format shall be accepted for processing.

Legislation exists that permit inspectors to inspect establishments where pharmaceutical activities are undertaken. Inspections are required by law and are a pre-requisite for the licensing of private and public establishments. Inspections are carried on the following entities: local manufacturers, private wholesalers, retail distributors, pharmacies, public warehouses, and pharmacies and dispensing points in health facilities. Inspections are carried out annually, routinely, and quarterly for private, public, and health facilities.

There are legal provisions that require importers, wholesalers, distributors and local manufacturers to be licensed. There is also legislation that requires both domestic and international manufacturers to comply with GMP guidelines. GMP requirements are published by the government. Wholesalers and retail distributors are also required by law to comply with Good Distribution Practices. National Good Distribution Practice requirements are published by the government. There is legislation that states that pharmacists must be licensed. Public and private pharmacies are also required to be licensed.

There is a laboratory, which is a part of the NMRA, where medicine samples are tested. Government inspectors collect medicine samples for post-market surveillance. Samples are tested for the following reasons:
•      For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities)
•      For quality monitoring in private sector (routine sampling in retail outlets)
•      When there are complaints or problem reports
•      For product registration
•      For public procurement prequalification
•      For public program products prior to acceptance and/or distribution

Guidelines on Pharmacovigilance has been provided on the LMHRA website. The document communicates among other things, application procedures, basic principles for efficient reporting, tools for pharmacovigilance, and the roles and responsibilities in ADR reporting.
There is a national pharmacovigilance center that is in charge of publishing ADR bulletins. Liberia also has a national ADR database. Reports from the national ADR database are sent to the WHO database in Uppsala. Liberia is a member of the WHO International Drug Monitoring Programme (Liberia Medicines and Health Products Regulatory Authority, 2013).

The Liberia Medicines and Health Products Regulatory Authority Act of 2010 provides for the regulation and control of clinical trials in the country. Part V Section 5(1) of the Act prohibits any person/organization to conduct a clinical trial on any medicines and health products without a written authorization from the Authority.
A person who wishes to conduct clinical trials of a medicine or health product has to submit to the Authority an application in prescribed form signed by him/her and accompanied with prescribed fees, an Ethical Clearance Certificate issued by any approved institute for clinical research and any other relevant information required by the LMHRA (Liberia Medicines and Health Products Regulatory Authority, 2014).

Legal provisions exist requiring authorization to import medicines into the country. There are also legal provisions that authorize the sampling of imported medication for testing. The imported medicines are also to be inspected at the ports of entry.

According to the WHO Pharmaceutical Country Profile on Liberia, the NMRA uses a computerized information management system to store and retrieve information on the various regulatory procedures, however further information is not provided on this information system is not provided (World Health Organization, 2011). The LMHRA has a website that provide guidelines and application documents for marketing authorization and clinical trials. The user can similarly upload completed clinical trial applications through the clinical trials portal on the website. A user can also fill a safety report on a drug on the website by entering an email, the message and supporting documents. There is also a downloadable ADR reporting form that can be filled and sent to the Safety Reporting portal on the same webpage.

The Libyan Health Law act number 106 of 1973 and its explanatory notes of 1975 state that registration of medicines within the Libyan Ministry of Health should precede the availability of any medicine in the Libyan market. However, there is a lack of an active registration process and this has created a negative impact on the quality of medicines in Libya.
Medicine registration is inactive and is mainly hindered by a lack of independence, minimal infrastructure, and the lack of appropriately trained personnel. The WHO has stated that medicines registration in Libya not only lacks the availability of a defined independent body, but also operates with a limited technical capacity and infrastructure that is not sufficient for the optimal approval of the quality, safety, and efficacy of medicines in the Libyan healthcare system.
The WHO also stated that appropriately equipped government quality assurance laboratories are lacking, and quality assurance is mainly undertaken in some schools of pharmacy with limited expertise and operating facilities.