Drug Approval Process at EMA vs SwissMedic

Drug development and approval process in EMA The European Medicines Agency (EMA) plays a central role in the scientific evaluation of human and veterinary medicinal products developed by pharmaceutical companies for use in the European Union (EU). Here's a breakdown of the drug development and approval process under the purview of the EMA: 1. Pre-submission Phase: Scientific Advice:

• Before formally submitting a marketing authorization application (MAA), companies can seek scientific advice from the EMA. This helps companies prepare applications in line with current regulatory and scientific standards.

• This advice can cover clinical and non-clinical studies, manufacturing information, and post-authorization requirements.

2. Submission of Application: Centralized Procedure:

• The centralized procedure is overseen by the EMA and allows companies to submit a single application to the EMA to obtain a marketing authorization that is valid throughout the EU, as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway).

• It's mandatory for certain types of medicines, such as biotechnology products, orphan drugs, and those intended for the treatment of AIDS, cancer, neurodegenerative disorders, and diabetes, among others.

3. Scientific Evaluation: Committee for Medicinal Products for Human Use (CHMP):

• The CHMP evaluates the MAA based on the drug's quality, safety, and efficacy.

• The process generally consists of:

  • Day 1: Start of procedure.

  • Day 120: CHMP reviews the reports and may ask questions.

  • Day 180: Applicant responds to the questions.

  • Day 210: CHMP issues an initial opinion.

• If the opinion is positive and after the standing matters are resolved (like product labeling), the CHMP adopts a final opinion and forwards it to the European Commission.

4. Decision by European Commission:

• The European Commission reviews the CHMP's opinion and usually issues a final decision regarding the authorization within 67 days.

• If the decision is favorable, the drug receives a centralized marketing authorization, making it valid in all EU and EEA countries.

5. Post-authorization Phase: Pharmacovigilance:

• Once a drug is authorized, there is a continuous monitoring of its safety, known as pharmacovigilance. Companies are required to submit periodic safety update reports (PSURs) and report any adverse reactions.

Renewal:

• The initial marketing authorization is valid for five years, after which it can be renewed based on an evaluation of the risk-benefit balance by the CHMP.

Variations:

• If a company wishes to make changes to their product (like a new indication or a change in manufacturing), they must submit a variation application for approval.

6. Conditional Approval and Accelerated Assessment:

• Conditional Marketing Authorization: For drugs that address unmet medical needs and for which the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, the EMA can grant a conditional marketing authorization. This is renewed annually.

• Accelerated Assessment: This can be granted if the product is expected to be of major public health interest. The timeframe for the CHMP review is shortened to 150 days (from the standard 210 days), but this doesn't guarantee approval.

It's worth noting that while the EMA provides the scientific evaluation of the medicine's benefits and risks, it's the European Commission that grants the final marketing authorization. Once authorized, the drug can be marketed in all EU Member States as well as EEA countries.

SwissMedic, being the principal regulatory authority in Switzerland, has its specific requirements and processes that need to be followed. Here are some specific details and nuances associated with SwissMedic's drug development, guidance, and approval processes:

1. Scientific Advice:

• SwissMedic offers scientific advice to companies, which can be invaluable for them in the planning and conduct of their drug development programs.

• These meetings are particularly beneficial for innovative therapies or when there's a lack of clear regulatory guidance.

2. Clinical Trial Authorization:

• Before conducting clinical trials in Switzerland, companies must obtain approval from SwissMedic and also from the responsible Ethics Committee.

• SwissMedic typically assesses the quality, safety, and manufacturing of the investigational medicinal product and the risk/benefit profile.

• The application must be submitted in the ICH eCTD (Electronic Common Technical Document) format.

3. Marketing Authorization Application (MAA):

• The application can be made via one of several procedures:

  • Ordinary Procedure: The standard procedure with an average processing time of 365 days.

  • Simplified Procedure: For known active substances with recognized efficacy and tolerability.

  • Notification Procedure: For homeopathic or anthroposophic products with no specific therapeutic indications.

• SwissMedic uses a modular documentation system in line with the ICH eCTD format. This makes it compatible with other major regulatory agencies, facilitating simultaneous submissions.

4. Foreign Evaluations:

• SwissMedic may take into account evaluations from recognized foreign agencies, such as the EMA or FDA. This is especially true for products that have recently been approved in the EU or US.

5. Fees:

• SwissMedic's activities are largely financed by the fees they charge for their services. The cost varies depending on the type of procedure. For instance, the ordinary procedure for a new active substance is notably more expensive than the simplified procedure for a known substance.

6. Post-marketing Commitments:

• Once a product is approved, SwissMedic may impose certain post-marketing commitments, including additional studies or the implementation of Risk Management Plans (RMPs).

7. Variations & Renewals:

• Any change made to an authorized medicinal product, regardless of whether it's based on a condition stipulated in the marketing authorization or not, is considered a variation and must be approved by SwissMedic.

• Renewals usually require submission of an updated benefit-risk profile of the product.

8. Guidance Documents:

• SwissMedic maintains a library of guidance documents, known as "Swissmedic Journal", which provides monthly updates on regulatory changes, guidelines, and other relevant topics.

9. Fast-Track Procedures:

• For products that address a significant unmet medical need or those that are of major public health interest, there's an option to have the assessment expedited. However, a justified request must be submitted, and SwissMedic will decide on a case-by-case basis.

Note:

While SwissMedic aligns with many international standards (especially ICH guidelines), its specific requirements and processes can be unique. Companies looking to obtain authorization for a medicinal product in Switzerland should familiarize themselves with SwissMedic's specific guidelines or consider hiring regulatory affairs experts with experience in the Swiss market.