Pharmaceutical Drug Product Registration in Malta

Process

Preclinical Research: Extensive preclinical research is carried out in labs and on animals to evaluate a drug’s safety and efficacy prior to human testing.

Clinical studies -Clinical Studies are carried out by pharmaceutical corporations to evaluate a drug’s safety and effectiveness in human subjects. These studies are carried out in stages, starting with a few volunteers in good health and working up to bigger patient groups.

Marketing Authorization Application: Following the conclusion of clinical trials, the pharmaceutical company applies directly to the Medicines Authority in Malta or to the European Medicines Agency (EMA) for a Marketing Authorization Application (MAA).

Assessment by Regulatory Authorities: The Malta Medicines Authority examines the MAA in cooperation with the European Medicines Agency (EMA) and the regulatory bodies of other EU member states. They evaluate the drug’s effectiveness, safety, and quality using information from preclinical and clinical research.

Decision on Approval: Regulatory bodies decide whether to authorize a medicine for marketing in Malta and the EU based on the evaluation. When making a choice, they might ask for further data or research.

Post-Marketing Surveillance: Pharmacovigilance systems are used to keep an eye out for any negative effects or safety issues with the drug after it has been approved. Any adverse incidents must be reported by pharmaceutical companies to regulatory bodies, who have the authority to take appropriate action, such as removing the medicine from the market if safety issues are raised.

Documents

1.Power of Attorney

2.Import License

3.European Drug Master File

4.Certificate of Suitability

 Generic Drug Approval

Submission of a Market Authorization Application (MAA): The pharmaceutical company that want to market a generic medication in Malta submits an MAA to the Malta Medicines Authority. This application has extensive data that shows the generic medication’s effectiveness, safety, and quality.

Review by Regulatory Authorities: Information from bioequivalence studies and the Medicines Authority’s assessment of the MAA are combined in Malta. Bioequivalence studies show that a generic medication is pharmaceutically comparable to its reference (originator) product and has the same physiological effects.

Approval Decision: The Medicines Authority decides whether to authorize the generic medication for marketing in Malta based on the evaluation. This choice considers the generic medication’s quality, safety, effectiveness, and bioequivalence.

Post-Marketing Surveillance: Following clearance, the generic medication is put under post-marketing surveillance to keep an eye on its efficacy and safety in everyday use. Pharmacovigilance activities include reporting and investigating adverse occurrences and quality issues.

Orphan pharmaceuticals

Regulation (EC) No 141/2000 and Commission Regulation (EC) No 847/200015, which implements it, are the two EU regulations that deal with orphan medical goods.

The legislation on orphan medications seeks to guarantee that patients with uncommon diseases have access to therapy by incentivizing sponsors to conduct research and development of medications for rare diseases. A 10-year period of market exclusivity following approval of an orphan medicinal product, protocol support, eligibility for Union and Member State initiatives supporting orphan medicinal product research and development, and the ability to request fee reductions from the EMA are some of the incentives.

License validity- 5 Years

Registration fee- 140000.€