Procedures: national / MRP / DCP / CP
Diapharm actively manages and supports all drug approvals under national and European law. This includes:
- Centralised Procedure (CP) with the EMA,
- Decentralised Procedure(DCP)in all EU member states, including the timely application for DCP slots
- Mutual Recognition Procedure (MRP) in all EU member states
- National drug approval procedures with the relevant national drug authorities (ANSM, BfArM, DKMA, MHRA, MEB, ...)
Diapharm handles all steps of the process through to approval – for both human medicines and veterinary medicines. All necessary information and documents are gathered and formatted according to the required CTD format (or NtA for veterinary medicines). Diapharm also supports the required assessments and evaluations for the CTD dossier, such as Environmental Risk Assessments (ERA).
The choice of the Reference Member State (RMS) in MRP and DCP procedures significantly impacts the course of the procedure. Diapharm understands the differences and supports the decision-making process. For DCP procedures, Diapharm also handles the application for a timely DCP slot.
In the approval process, Diapharm supports the Scientific Advice, handles the review and resolution of change and supplement requests from the authorities ("deficiency notice"), and ensures successful drug approval.
Well-established Use (WEU)
For long-established medicines with a "Well-Established Use" (WEU), the legislator has simplified the approval requirements under Article 10a of EU Directive 2001/83/EC (in Germany: Section 22, Paragraph 3 of the AMG). Instead of submitting results from (own) preclinical and clinical studies, the applicant may refer to relevant scientific documentation, such as published research in professional journals. During the drug approval process, it must be demonstrated that the product has recognized efficacy and safety. A key requirement for a WEU approval is that the medicine has been used within the European Community for at least ten years.
Traditional Registration (THMP)
For herbal medicines that have been used for decades, the European Union has established the "Traditional Registration" system: This is a simplified approval process under EU Directive 2001/83/EC, Articles 16a – 16i, and in Germany under Sections 39a-d of the AMG. The drug manufacturer must demonstrate that the medicine has been used for the requested indication for at least 30 years, with a minimum of 15 of those years in Europe.
Diapharm determines which medicinal products are eligible for a WEU approval or traditional registration, prepares the necessary documentation, and supports the approval or registration process
Homeopathic Medicines
The marketing of homeopathic medicines, like all medicinal products, is subject to regulatory oversight. A distinction is made between approval (with the specification of a therapeutic indication) and registration (without the use of indications) for homeopathic medicines.
Within the European Union, the conditions for registering homeopathic medicines are uniform, while national approval requirements vary widely. In Germany and Austria, applicants are free to pursue either registration or approval, provided they meet the relevant legal requirements. The Swiss Complementary and Phytomedicine Ordinance (KPAV) sets out specific requirements for the production of complementary and phytomedicines and establishes the conditions for their simplified approval and notification-based approval process.
A homeopathic medicine is primarily defined by its manufacturing process. Regulations for producing homeopathic preparations are outlined in the German Homoeopathic Pharmacopoeia (HAB) or the French Pharmacopoeia (Ph. Franc.). Manufacturing guidelines are increasingly being incorporated into the European Pharmacopoeia (Ph. Eur.), Monograph 01/2011:2371.
To achieve European harmonization for homeopathic medicines, the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA) has been working since 2002 to develop guidelines for the evaluation of homeopathic preparations. To date, no guidelines or regulations have been adopted by the Commission. The HMPWG has published guidelines on quality, safety, and homeopathic use on its website, which are used by all European countries for the assessment of homeopathic medicines.
For the approval/registration of a homeopathic medicine, no preclinical or clinical studies are required. The safety and, where applicable, the efficacy of a single substance or the safety, efficacy, and plausibility of a combination can be demonstrated through repertorization and the Materia Medica.
With homeopathic databases, a comprehensive Materia Medica, in-depth expertise, and years of experience in Regulatory Affairs, Diapharm supports pharmaceutical companies in the approval and registration of homeopathic medicines.
