What are the main documents required when registering a drug?
@Evert_Manders: Does Medicines for Society (Medicijn voor de Maatschappij) has an overview of the main documents?
The registration process for a medicinal product requires a carefully prepared registration dossier containing various documents. The most important documents are:
- Summary of Product Characteristics (SmPC): this document provides detailed scientific information about the medicinal product, such as indications, dosage, side effects, contraindications, and usage instructions. It is an essential part of the registration and is used by healthcare professionals when prescribing and dispensing the medicinal product. It is also an important document in the risk assessment by the authorities.
- Preclinical and clinical data: this includes the results of toxicological and pharmacological studies, as well as data from clinical trials demonstrating the safety and efficacy of the medicinal product. The dossier must contain both the preclinical data (such as animal studies) and the clinical data supporting the product’s effect in the target population.
- Chemical-pharmaceutical data: this document contains detailed information about the composition of the medicinal product, the production methods, the raw materials used, and the quality control measures. The focus is on the production stability and consistency of the final product, as well as control over the purity and quality of the ingredients.
- Approvals and certificates: this includes certificates of origin, Good Manufacturing Practice (GMP) certificates, and other documents demonstrating compliance with international standards for production and quality control. These documents serve as proof that the product meets the required manufacturing criteria and is safe for use.
More information can be found at: Marketing authorisation | European Medicines Agency (EMA) (europa.eu)
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