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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Medicinal Product Regulation: Portugal׳s Framework.

Maria Teresa Herdeiro1, Paulo D Bastos2, António Teixeira-Rodrigues3

  • 1Department of Medical Sciences and Institute for Biomedicine - iBiMED, University of Aveiro, Aveiro, Portugal; CESPU, IINFACTS, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Gandra, Portugal.

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Portugal

Keywords:
National Regulatory AgencyPortugalmarketing authorizationmedicinal products regulation

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Area of Science:

  • Pharmaceutical Regulation
  • Medicinal Products
  • Drug Approval Processes

Background:

  • The pharmaceutical industry is highly regulated globally.
  • Understanding national legal frameworks is crucial for drug approval and marketing.
  • Portugal's regulatory landscape for human medicines is managed by INFARMED.

Purpose of the Study:

  • To outline the statutes and procedures for medicinal products in Portugal.
  • To describe the role of the National Medicines and Health Products Authority (INFARMED).

Main Methods:

  • Analysis of data on marketing authorizations, variations, pricing, and reimbursements.
  • Sourcing information from INFARMED website, Infomed database, and national authority reports.
  • Review of organic laws, acts, and law decrees from Diário da República.

Main Results:

  • Portugal ranked fifth in the European System of Medicines Evaluation in 2015.
  • Approximately 80% of drug applications approved in Portugal in 2015 were generics, primarily for nervous system treatments.
  • INFARMED ensures drug quality, safety, and efficacy throughout the product lifecycle.

Conclusions:

  • Generic drugs have significantly impacted the Portuguese pharmaceutical market.
  • There is a growing trend in applications for biological and biotechnological substances.
  • INFARMED plays a vital role in safeguarding patient safety in Portugal.