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Pharmaceutical Drug Product Registration in Germany

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Pharmaceutical Drug Product Registration in Germany

Pharmaceutical Drug Registration in Germany

MOH

Federal Ministry of Health

MOH website 

https://www.bundesgesundheitsministerium.de/en/ 

Regulatory Authority

Federal Ministry of drugs and medical devices

Regulatory Authority Website 

https://www.bfarm.de/EN/Home/_node.html 

Local Authorized Representative Required

Yes

Drug Approval Procedures  

  • Decentralized Process

The Decentralized Procedure (DP) can be used for medications that are not yet approved in the European Union. Manufacturers of these medications may submit simultaneous permission applications to several EU member states. This process is governed by Directive 2004/27/EC. Any state that is only one member of the DP may decide to evaluate the application on its own.

The Decentralised Procedure is divided in six steps:

  • Pre-procedural steps
  • Validation phase • Assessment step I
  • Assessment step II
  • Discussion at the CMDh, if needed
  • National step

Documents for Decentralized Procedure

1. Power of Attorney

2. Import License

3. European Drug Master File

4. Certificate of Suitability

  • Mutual Recognition Procedure

Market authorization issued in one EU member state is recognized in other EU member states under the Mutual Recognition Procedure (MRP). Only in cases where the manufacturer has already received market permission in an EU nation is MRP applicable. The Directive 2001/83/EC establishes the rules for market authorization through MRP. 

It is necessary to make sure that all MRP applications are comparable if they are sent to multiple EU nations. The nation reviewing the application is referred to as the Reference Member State, and it is its responsibility to inform the other relevant Member States of the application’s status.

  • Centralized Procedure

 Manufacturers can submit a single Market Authorization Application (MAA) to the EMA through the consolidated approach. Manufacturers who intend to sell their goods both inside the EU and in Iceland, Liechtenstein, and Norway—members of the European Economic Area (EEA)—will find the CP helpful. 

Following European Commission (EC) approval, producers can sell their products to healthcare professionals through a centralized mechanism under Regulation (EC) 726/2004.

  • National Procedure

The national procedure (NP) authorizes medications not covered by the centralized procedure or approved prior to the EMA’s formation. Manufacturers who want to get market authorization in particular EU member states, can find it helpful. 

Applications in this procedure are examined by the relevant EU member state authorities. Every EU member state has its own national protocol.

NDA Approval Process

1. Preclinical Development: Before a medicine is evaluated in humans, rigorous preclinical studies are performed to determine its safety and efficacy. This phase includes laboratory testing and animal experiments.

2. Clinical Trials: If the preclinical tests are successful, the medicine will enter clinical trials. These trials have three phases:

Phase I: Conduct small-scale investigations on healthy volunteers to assess safety.

Phase II includes larger patient studies to examine effectiveness and safety.

Phase III includes large-scale patient studies to validate efficacy, evaluate side effects, and compare the medicine to existing treatments.

  1. Marketing Authorization Application (MAA): Following successful clinical studies, the drug developer files a Marketing Authorization Application with the EMA. The EMA evaluates the application and collaborates with national regulatory bodies, such as the BfArM in Germany.

4. BfArM Evaluation: The BfArM reviews the MAA, with a focus on topics that are significant to Germany. This evaluation comprises a review of quality, safety, and efficacy information.

  1. Decision by Regulatory Authorities: Based on the evaluations, regulatory authorities decide whether to give marketing license. The decision is generally made based on the drug’s benefit-risk balance.

6. Post-marketing monitoring: Following approval, the medicine is regularly checked for safety using post-marketing monitoring. Any new safety concerns or bad responses are evaluated, and regulatory action may be taken as needed

Generic Approval

1. Market Authorization Application (MAA): The generic medication company files a Marketing Authorization Application with the EMA. This application provides data confirming the generic drug’s bioequivalence with the reference (innovator) product.

2. Reference Product Selection: The generic medicine is compared to a reference product that has already acquired marketing approval. This reference product is often an innovative drug that has been thoroughly tested to ensure its safety and efficacy.

  1. Bioequivalence studies: Bioequivalence Studies are conducted by generic medication makers to establish that their product is pharmaceutically and bioequivalent to the reference product. These tests measure the rate and extent of medication absorption in relation to the reference product.
  2. Quality Documentation: The generic medicine application must include detailed documentation on the product’s quality, safety, and efficacy, such as manufacturing processes, specifications, stability data, and analytical procedures.

5. Evaluation BfArM: The BfArM in Germany examines generic medicine applications, focusing on bioequivalence data and ensuring that the generic product meets the necessary quality and safety criteria. This evaluation is being done with the EMA.

  1. Decentralized Procedure (DCP) also known as Mutual Recognition Procedure (MRP): Generic medications are frequently approved using a decentralized or mutual recognition system. This means that the application is evaluated simultaneously by numerous European Union (EU) member states, including Germany.

7. Decision on Marketing license: After assessing the generic drug, the BfArM and other pertinent EU member states decide whether to grant marketing license. Based on the product’s quality, safety, efficacy, and bio equivalency, a decision is reached.

Biologic Drug Approval

1. Development & Preclinical Studies: Before moving on to human trials, biologic drugs—which are usually complex chemicals made from live cells—go through a rigorous preclinical testing process to determine their safety and efficacy.

2. Clinical Trials: Because biologics are complicated medicines, they go through clinical trials in a manner akin to small molecule pharmaceuticals, but with some distinctions. Phase I, II, and III clinical trials assess safety, effectiveness, and dose. Phase I of these trials typically comprises fewer participants, and later stages have progressively more individuals.

3. Marketing Authorization Application (MAA): The biologic drug developer submits a Marketing Authorization Application to the European Medicines Agency (EMA) following the successful completion of clinical studies. Comprehensive information about the biologic’s effectiveness, safety, and quality is included in the application.

4. Centralized Process: In Europe, biologics are typically subject to the centralized process. This indicates that the marketing authorization is valid in all member states of the European Union (EU), including Germany, after the EMA reviews the application and grants approval.

5. BfArM Involvement: Working with the EMA, the BfArM takes an active part in evaluating the MAA for biologics. Like other EU members, Germany offers feedback on the application’s quality, safety, and efficacy, among other issues.

6. CHMP: The EMA body known as the body for Medicinal Products for Human Use (CHMP) conducts the scientific review of applications seeking marketing authorization. It offers suggestions to the European Commission, which has the power to approve a product for sale.

7. Conditional Approval or Accelerated Assessment: Biologic medications may be qualified for one of these procedures in specific circumstances, giving patients who have unmet medical needs faster access.

8. Post-Marketing Surveillance: Following approval, biologic medications are subjected to ongoing safety monitoring via post-marketing surveillance. This entails reporting any unfavorable occurrences and continuing safety monitoring.

Registration Timeline

12 –18 Months

License Validity 

5 Years

Registration Fee for Generic

15,600 € for Generic Application in National Procedure

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