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Thursday, November 14, 2024

LMHRA REVIEWS AUTHORITY’S ACT OF 2010 – DRAFTS EIGHT NEW REGULATIONS

Date:

The Liberia Medicines and Health Products Regulatory Authority (LMHRA) has successfully drafted eight new regulations and is currently reviewing the Authority’s Act of 2010 for potential amendments. The week-long drafting and revision process took place in Buchanan, Grand Bassa County.

At the commencement of the drafting and revision activities, LMHRA Managing Director Dr. Luke Bawo underscored the importance of updating the existing Act, noting that several critical areas were overlooked in the 2010 legislation. He emphasized the need for revisions to reflect new regulatory roles and to align with international best practices and pharmaceutical regulatory standards.

Dr. Bawo pointed out that various issues not addressed in the current Act, including the decentralization of the Authority’s operations across Liberia, the establishment of roles for the Deputy Managing Director and Directors, enhancements to the Quality Control Laboratory, and other administrative and regulatory matters.

“As we review these regulations and the Act, let’s collaborate to ensure they positively impact Liberia’s pharmaceutical sector over the next decade,” Dr. Bawo stated.

Dr. Michael Chu Nepay, LMHRA Programs & Planning Coordinator, provided an overview of the retreat, highlighting the objective of drafting new pharmaceutical regulations to ensure LMHRA maintains modern policies for regulating medicines and health products in Liberia.

As the statutory body of the Government of Liberia, LMHRA is tasked with ensuring the safety, efficacy, and quality of all medicines and health products available in the country.

Among the drafted regulations for potential promulgation are those that define the roles, responsibilities, and functions of institutions involved in the regulatory system; regulations for addressing complaints and appeals against regulatory decisions; and guidelines for the publication of deferred and rejected products.

Additional regulations include those focused on qualifying reference standards, recognizing relevant decisions from other National Regulatory Authorities (NRAs) and international bodies, and implementing a risk-based approach to product testing.

Furthermore, regulations for Good Distribution Practice (GDP) and Good Storage Practice (GSP) inspections, as well as those mandating LMHRA to conduct risk-based post-marketing surveillance procedures, have also been drafted.

At the conclusion of the retreat, Dr. Bawo expressed his gratitude to USP/PQM+, the World Health Organization (WHO), and other partners for their invaluable contributions. He also thanked the Government of Liberia, particularly the Ministry of Health and the Law Reform Commission, along with LMHRA staff for their collaborative efforts throughout the drafting and revision process.

Deputy Health Minister for Planning & Policy, Malayah Chieyoe, congratulated all participants involved in the regulatory and Act reviews. On behalf of Health Minister Dr. Louise Kpoto, he reaffirmed the Ministry’s strong support for LMHRA.

The Deputy Health Minister expressed confidence that the collaborative efforts of LMHRA’s management and partners would lead to significant health improvements for citizens, in alignment with President Joseph Nuymah Boakai’s ARREST Agenda.

In her closing remarks, LMHRA Deputy Managing Director Dr. Patricia Quaye-Freeman commended the participants for their open-minded collaboration aimed at developing regulations and guidelines that, once enacted, will enhance health outcomes for the Liberian population.

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