Transmission Result Reports pursuant to 42b AMG (Arzneimittelgesetz, German Medicinal Products Act)
Obligations for pharmaceutical entrepreneurs
Pursuant to Section 42b sub-section 1 AMG pharmaceutical entrepreneurs who place a medicinal product, which is subject to the obligation of a marketing authorisation and intended for use on humans, on the market within the scope of the AMG shall place reports on the results of all confirmatory clinical trials substantiating efficacy and safety of the medicinal product at the disposal of the competent higher federal authority. These reports must be submitted within six months after the marketing authorisation has been granted. This obligation applies regardless of whether one or more than one study centres were located in Germany, i.e. even if the entire clinical trial was conducted in a country other than Germany.
With the coming into force of the Pharmaceutical Market Restructuring Act in the statutory health insurance system (Arzneimittelmarktneuordnungsgesetz – AMNOG,) as of 1 January 2011, Section 6 of the AMG (German Medicinal Products Act) was extended by Section 42b – Publication of results of clinical trials.
Section 42b AMG refers to the provision of result reports of clinical trials with authorised medicinal products for the publication by the higher federal authorities. While the provision laid down in sub-section 1 concerns pharmaceutical entrepreneurs who place a medicinal product, which is subject to the obligation of marketing authorisation, the provision in sub-section 2 is addressed to sponsors of clinical trials who are conducting a clinical trial with a medicinal product in at least one study centre in Germany, and this product has already been granted a marketing authorisation.
This page provides an overview of the obligations of the parties involved in clinical trials and the requirements for the result reports.
Obligations for sponsors of clinical trials
Sponsors of clinical trials with an investigational medicinal product which has already been granted a marketing authorisation and for which at least one study centre is located in Germany are obliged, pursuant to Section 42b sub-section 2 AMG to submit the results of the clinical trial within one year after completion of the clinical trial pursuant to Section 42b sub-section 1, regardless of whether or not the clinical trial was conducted for the purpose of a variation to a marketing authorisation.
The regulations laid down in Section 13 sub-section 9 GCP-V for the submission of reports on results of clinical trials remain unaffected by the regulations laid down in Section 42b AMG. However, as a rule, an additional submission of a report pursuant to Section 13 sub-section 9 GCP-V is not required from the sponsor if he fulfils his obligation of Section 42b sub-section 2 AMG entirely, unless the higher federal authority requires further-reaching information pursuant to Section 13 sub-section 9 GCP-V.
Requirements for the content
The reports shall be prepared in the format laid down in Section 42b sub-section 3 AMG. Accordingly, the reports, which can be prepared in English or in German, must contain all the results of the clinical trials, whether they are favourable or not. The reports must contain information on essential modifications to the trial protocol made in retrospect as well as interruptions and early terminations of clinical trial.
Applicability in retrospect
For medicinal products which have been granted a marketing authorisation before 1 January 2011, the appropriate transitional provisions pursuant to Section 145 AMG shall apply. These provisions lay down that for all medicinal products which were already authorised or completed on 1 January 2011, the reports on the results shall be placed at the disposal of the competent higher authority by 1 July 2012 if an authorisation for the appropriate clinical trial was required by the competent higher federal authority since 6 August 2004, i.e. an application was made for the conduct of the clinical trial in Germany.
Special case: Generically authorised medicinal products (BfArM only)
In line with sub-section 4 of the announcement on the publication of the results of clinical trials pursuant to Section 42b AMG of 3 August 2011 (see below), no reports on the results shall be placed at the disposal of the competent authority for generically authorised medicinal products for which no confirmatory but only bioequivalence studies have been submitted for authorisation, but only a reference to the originator product concerned shall be provided. This shall be done in the web portal for Section 42b AMG in the PharmNet.Bund system.
Format of the result reports
The result reports pursuant to Section 42b AMG shall be prepared in the format of the synopsis of the ICH Topic E 3 - Note for Guidance on Structure and Content of Clinical Study Reports. The minimum information required can be found in the table below:
Minimum information required in accordance with ICH E3
- Name of Sponsor/Company
- Name of Finished Product
- Name of Active Substance
- Individual Study Table: Referring to Part of the Dossier (Volume, Page)
Note: This information is required only in the case of a submission in connection with a marketing authorisation dossier
- Title of Study
Note: It must be clearly indicated that reference is made to the last version of the protocol including all amendments. The amendments must be listed and identified.
- Study centre(s)
- Publication (reference)
- Studied period (years): date of first enrolment, date of last completed
Note: Interruptions or early terminations of clinical trials with reasons shall also be indicated here
- Phase of development
- Number of patients (planned and analysed)
- Diagnosis and main criteria for inclusion
- Test product, dose and mode of administration, batch number
- Duration of treatment
- Reference therapy, dose and mode of administration, batch number
- Criteria for evaluation: Efficacy, Safety
- Statistical methods
- Summary – Conclusions: Efficacy Results, Safety Results, Conclusion
- Date of report
For further details please refer to "Bekanntmachung zur Veröffentlichung der Ergebnisse klinischer Prüfungen nach § 42b des AMG vom 3. August 2011" ("Announcement regarding the publication of results of clinical trials pursuant to Section 42, AMG of 3 August 2011", published in the Federal Gazette No 127 of 24 August 2011 page 2975) and the list of questions and answers on this subject:
- Belanntmachung zur Veröffentlichung der Ergebnisse klinischer Prüfungen nach § 42b des Arzneimittelgesetzes (AMG) (Announcement regarding the publication of the results of clinical trials pursuant to Section 42b of the German Medicines Act (AMG))
- Announcement regarding the publication of the results of clinical trials in accordance with Section 42b of the Medicinal Products Act (Unofficial translation provided by the German Association of Research-based Pharmaceutical Companies, VfA)
- Questions and answers concerning Section 42b AMG
Transmission of the result reports by means of the web portal
The announcement of 3 August 2011 provides for electronic submission of the reports. A web-based submission portal is available in the internet pages of the PharmNet.Bund portal for these purposes. The report must be available as a pdf file and shall then be uploaded to the competent higher federal authority in the web portal. To obtain the web portal in PhamNet.Bund follow this link:
Publication of the result reports
The competent higher federal authority checks the details in the synopsis as well as the data and documents attached. In the case of doubt, additional information can be requested concerning this. A note will be published with the result reports on clinical trials stating that these reports contain the data from the pharmaceutical entrepreneur or the sponsor. The reports are published under PharmNet.Bund in the section Clinical Trials and/or the appropriate information on the medicinal products. As soon as the portal is activated for the purpose of publication, the appropriate information will be shown in this section.