It applies to all the member states of the EU and is in use for medicinal products intending for human use. Since its induction in 1995, the CP has become a mandatory requirement for biotechnological products. Including orphan medicinal products, and human products containing a new active substance intended for the treatment of specific diseases.
Mandatory Requirements for CP
In the EU before May 20, 2004, are subject to the mandatory requirement for CP. These products are intending for the treatment of AIDS, cancer, neurogenerative disorders, or diabetes. The CP is the only regulatory process that can be in use to obtain a marketing authorization for these types of products.
Optional Requirements for CP
Products that contain new active substances that were not in authorizing category in the EU before May 20, 2004. But do not fall under the above-mentioned categories, are not subject to the mandatory requirement for CP. Similarly, products that constitute a significant therapeutic, scientific, or technical innovation, and products that require community authorization in the interest of patients’ or animal health, may also be subject to the CP, but it is not mandatory.
Templarpharma’s Experience with CP
Templarpharma is a leading global regulatory solutions and services company that specializes in assisting generic medicinal product manufacturers through the Centralized Procedure (CP). We adheres to the requirements of submissions to Health Authorities (HAs) in the EU and supports the preparation of Product Development Reports.
Preparation for CP
To prepare for the CP process, a comprehensive dossier is compiled. It contains information about the medicinal product, including the active substance, its quality, safety, and efficacy. The dossier also includes details about the manufacturing process. The product’s labeling and packaging, and information about the pharmacovigilance and risk management systems that will be implementing.
Once the dossier is complete, it must be submit to the European Medicines Agency (EMA) for evaluation. The EMA is responsible for the scientific assessment of the medicinal product. The evaluation process includes a review of the dossier and any additional data that may be in request of the EMA or the member states’ regulatory authorities.
The submission of the dossier is a critical step in the CP process, as it contains all the information necessary for the EMA to make an informed decision about the safety, efficacy, and quality of the medicinal product. Therefore, it is crucial to ensure that the dossier is complete, accurate, and meets all regulatory requirements.
Evaluation and Approval
The EMA evaluates the CP, assessing the medicinal product with member states’ regulatory authorities. It reviews the dossier and additional data as needed. After evaluation, the EMA issues an opinion on safety, efficacy, and quality. The European Commission gives final approval.
Expert Guidance and Support
In summary, the Centralized Procedure (CP) is a regulatory process used to obtain a marketing authorization for medicinal products in the European Union (EU). It is mandatory for certain types of products and optional for others. Templarpharma has extensive experience in assisting generic medicinal product manufacturers. Through the CP process and can provide expert guidance and support in preparing dossiers. Also handling post-approval submissions and renewals, and ensuring compliance with regulatory requirements. If you require assistance with the CP process, contact Templarpharma today for expert guidance and support.
Expertise in Centralized Procedure
- Providing legal representation as a Marketing Authorization Holder (MAH) for medicinal product manufacturers who lack establishments in the European Economic Area (EEA).
- Regulatory consultation and strategic support during the developmental stage of medicinal products.
- Offering support in the selection of dissolution parameters, multimedia, and for performance of dissolution for both test products and Reference Medicinal Products (RMP).
- Preparation of Product Development Reports with consideration of the discriminatory nature of media.
- Designing specifications for finished products, API, in-process and intermediates.
- Providing advice on selecting Regulatory submission procedures based on the MAH’s requirements.
- Assistance with pre-submission administrative activities along with the Centralized Procedure.
- Advice for appointment/consultation of Qualified Person (QP) for quality, and Qualified Person for Pharmacovigilance (QPPV) for applicants outside EEA who lack their own QP and QPPV.
- Consultation for batch release testing site and batch control site testing if the applicants do not have their own sites in the EEA.
- Regulatory assessment and gap-analysis of source documents and already registered dossier for their regulatory adequacy.
- Compilation, technical review, finalization, publishing, and submission of Marketing Authorization Application (MAA) to EU Health Authorities (HAs).
- Preparation of regulatory strategy for responding to HA queries (RTQs).
- Preparation of responses to HA queries (HAQs) with supporting documents/data and scientific rationale to avoid delay in approval.
- Evaluation of change controls and supporting documents.
- Preparation of variation submission strategy.
- Compilation and submissions of variations and renewals for MAA.
- Tracking renewal submissions for MAA and Centralized Procedure.
- Follow-up with regulatory agencies for the approval of the MAA.
- Assistance in the preparation of the Pharmacovigilance System Master File (PSMF).
- Preparation of Risk Management Plans (RMP) and Benefit-Risk Assessment Reports (BRAR).
- Preparation of pediatric investigation plans (PIP) and waivers.
- Regulatory support for clinical trials, including protocol preparation, clinical study reports, and regulatory submissions.
- Assistance in the preparation of Investigational Medicinal Product Dossiers (IMPD) and Investigational New Drug Applications (IND).
- Support in the preparation and submission of Annual Safety Reports (ASR) and Periodic Safety Update Reports (PSUR).
- Assistance in the preparation and submission of Orphan Drug Designation applications.
- Support in the preparation and submission of Scientific Advice Procedures.
- Regulatory intelligence and monitoring of changes in regulatory guidelines and legislation.
- Provision of training sessions and workshops for Regulatory Affairs.
- Assistance in the preparation of Standard Operating Procedures (SOPs) and Working Instructions (WIs).
- Assistance in the preparation of other regulatory documents and communications with regulatory authorities.