BfArM

1. Federal Opium Agency

2. Research

2.1. Pharmacogenomics

2.2. Pharmacoepidemiology

2.3. Medical Devices safety

3. About

4. Drugs

4.1. Licensing procedures

4.1.1. National

4.1.2. MRP

4.1.3. DCP

4.1.4. Centralised

4.2. Follow up procedures

4.2.1. National variations

4.2.2. Renewal

4.3. Pharmacovigilance

4.3.1. DATABASE Adverse Drug Reactions

4.3.2. Risk information

4.3.3. Comitee and boards

4.3.4. PSURs

4.3.5. Bulletin on drug safety

4.4. Pivotal topics

4.4.1. e submission

4.4.2. Standard licensing & registration

4.4.3. Who certificates?

4.5. Clinical trials

4.5.1. Approval process

4.5.2. Non-interventional trials

4.5.3. VHP process

4.5.4. Compassionate use

4.6. Drug informations

4.6.1. Supply shortages

4.7. Approval categories

5. Medical Devices

5.1. Risk identification and assessment

5.2. Clinical evaluation / performance evaluation

5.2.1. Consultation process

5.2.2. Application for approval

5.2.3. Request for waiver of authorization

5.2.4. Subsequent changes

5.2.5. Serious adverse events (SAEs)

5.2.6. Termination and termination of tests

5.3. Legal Framework