Gov’t Launches New Medicine Policy Aimed at Streamlining Drug Imports

The Maldives government launched its National Medicine Policy yesterday, establishing guidelines to facilitate the importation of quality medications. Developed by the Maldives Food and Drug Authority (MFDA), the policy outlines a six-year strategy to ensure timely access to high-quality medicine without discrimination.

A key change is the potential for simplified import procedures for drugs originating from countries recognized by the World Health Organization as having robust drug regulatory systems. Implementation will follow the development of specific MFDA guidelines.

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An MFDA official confirmed significant concessions are under consideration for medication imports from these “Category 1” countries. The initial list comprises 45 nations across Europe and Asia, including Malaysia and Singapore. Currently, 18 countries have been granted Category 1 status.

Under the new policy, importers from Category 1 countries would potentially only need to provide a Good Manufacturing Practice (GMP) license and drug stability documentation along with a sample. Current import procedures are more extensive, often requiring additional paperwork that can include confidential company information. Pharmacy operators have raised concerns that these requirements hinder the import of quality medicines.

An MFDA official noted that the current process necessitates the submission of up to 45 documents and could involve a 90-day approval period. The new policy targets a significantly reduced registration time frame of a maximum of 15 days.

The MFDA expects to publish detailed guidelines within a month. The anticipated outcome is enhanced quality control and a more streamlined import process for medications in the Maldives.

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