The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI) jointly publish a quarterly drug safety bulletin called
You can find the current edition (German only) using this link.
Further news from the higher federal authorities:
December 2023: PEI designated as an EU Reference Laboratory for in vitro Diagnostic Medical Decives (read more)
November 2023: BfArM and PEI inform about global campaign for reporting of suspected adverse events (read more)
October 2023: BfArM publishes updated information on admissability of Digital Health Application (DiGA) data processing outside Germany (read more)
September 2023: Bfarm publishes updated guidance on Digital Health Applications (DiGA) (read more)
August 2023: BfArM and PEI publish updated guideline on naming of medicinal products (read more, German only)
May 2023: PEI informs about International Clinical Trials Day (read more)
March 2023: BfArM publishes update of list of registered Ethics Committees according to §41a AMG (read more)
March 2023: BfArM invites to dialogue meeting on interoperability requierements for digital health applications (read more, German only)
January 2023: PEI informs about end of transition phase for clinical trial applications via CTIS (read more)
May 2022: BfArM informs about suspension of market authorizations due to deficient clinical trails (read more, German only)
April 2022: PEI invites to dialogue meeting on IVDR (read more)
March 2022: BfArM publishes update of list of registered Ethics Committees according to §41a AMG (read more, German only)
February 2022: BfArM informs about Clinical Trials Regulation CTR and Clinical Trials Information System CTIS (read more, German only)
November 2021: PEI informs about global campaign for reporting of suspected vaccine adverse events (read more)
October 2021: BfArM informs about advisory service for manufacturers of digital health applications (read more)
August 2021: BfArM announces end of CTR (EU 536/2014) Pilot Project (read more)
June 2021: BfArM has updated the FAQ on clinical trials with medical devices to address the recent regulatory changes (read more) - please note: the English version is not yet updated, please find German version here
June 2021: PEI publishes biennial report (read more)
April 2021: BfArM invites to dialogue meeting on decentralised clinical trials (read more)
Fenruary 2021: BfArM and PEI publish supplementary recommendations to the new version of EMA's guidance on clinical trials during the Corona pandemic (read more)
February 2021: BfArM informs about research project on the use of algorithms for identification of serious adverse effects (read more)
February 2021: PEI and BfArM publish draft announcement for the follow-up of spontaneous reports of suspected cases of adverse effects for public consultation (read more)
December 2020: PEI launches app-based observational study on tolerability of COVID-19 vaccines (read more)
December 2020: PEI approves another COVID-19 vaccine study in Germany (read more)
November 2020: BfArM informs about international campaign for reporting of adverse drug reactions (more)
October 2020: PEI approves another COVID-19 vaccine study in Germany (read more)
September 2020: BfArM publishes German version 2021 of final version of ICD-10 (read more)
August 2020: PEI informs about new findings on the spike protein of SARS-CoV-2 (read more)
June 2020: PEI approves second COVID-19 vaccine study in Germany (read more)
June 2020: BfArM and PEI inform about current regulations regarding the publication of the names of investigators and trial sites in result reports of clinical trials (read more)
May 2020: BfArM and DIMDI - German Institute for Medical Documentation and Information - merge (read more)
April 2020: PEI approves first COVID-19 vaccine study in Germany (read more)
April 2020: PEI approves first COVID-19 therapy study with convalescent plasma (read more)
March 2020: BfArM and PEI publish Supplementary Recommendations to EMA's Guidance on clinical trials during the COVID-19 pandemic (read more)
March 2020: BfArM invites to dialogue meeting on digitisation and telemedicine in clinical trials (read more)
January 2020: BfArM and PEI request questionnaire regarding risk-based pharmacovigilance inspections (read more)
December 2019: BfArM and PEI publish new recommendations for non-interventional trials on medicinal products (read more)
November 2019: BfArM celebrates 25th anniversary and reflects on the digital future (read more)
November 2019: BfArM informs about absence of critical incidents in clinical trials in Germany (read more)
November 2019: PEI launches new website (read more)
November 2019: PEI informs about first Ebola vaccine authorisation (read more)
October 2019: BfArM kicks off annual lecture series on clinical trials on medicinal products (read more)
August 2019: PEI informs about electronic application for approval of clinical trials on medicinal products (read more)
August 2019: PEI informs about mutual recognition of US and European inspections (read more)
August 2019: BfArM invites to dialogue meeting on a regulatory update regarding pharmacovigilance (read more)
July 2019: BfArM informs about call to publish clinical trial results in EU database (read more)
June 2019: PEI publishes biennial report (read more)
May 2019: PEI informs about challenges for mutual recognition of marketing authorizations (read more)
April 2019: BfArM invites to dialogue meeting on current challenges with medicinal products of the particular therapeutic systems (read more)
March 2019: BfArM invites to dialogue meeting on current GCP requirements in clinical trials (read more)
February 2019: BfArM publishes updated list of ethics committees registered for clinical trial approval according to EU 536/2014 (read more)
February 2019: PEI updates information about its Brexit preparations (read more)
January 2019: BfArM updates Brexit recommendations for UK sponsors in clinical trials (read more)
December 2018: BfArM informs about Brexit impact on future and running clinical trials (read more)
November 2018: BfArM informs about German-Austrian pilot project on clinical trial approvals according to EU 536/2014 (read more)
November 2018: Apparently reacting to critical media coverage BfArM informs about their own general dossier on the topic of Medical Devices (read more)
November 2018: PEI informs about international campaign by medicines authorities on adverse effects reporting by patients (more)
October 2018: PEI informs about new dialogue-series with the German Medicines Manufacturers' Association (read more)
September 2018: PEI informs about new online portal for reporting of adverse drug reactions (read more)
August 2018: BfArM publishes annual report 2017/2018 (read more)
August 2018: PEI informs about first European approvals for CAR-T cell therapeutics (read more)
July 2018: BfArM invites to dialogue meeting on distinction between clinical trials, non-interventional trials and other research projects on medicinal products (read more)
May 2018: BfArM invites to dialogue meeting on cyber security in medical devices (read more)
April 2018: PEI informs about fewer animal experiments in medicines testing (read more)
April 2018: PEI launches a survey on the safety of donating blood (read more)
February 2018: BfArM and PEI inform about preparations for possible Brexit (read more) (read more)
February 2018: PEI informs about EudraVigilance database of supsected adverse drug reaction reports and closure of previous German database (except for vaccines) (read more)
January 2018: BfArM publishes the first (and not yet in force) case assignement plan for the registered ethics committees pursuant to Section 41b (2) AMG (read more)
January 2018: BfArM publishes the list of ethics committees registered pursuant Section 41a AMG (read more)
Sorry, news from before 2018 are not availbale in English.
If you want to learn more about the past activities of BfArM and PEI, please contact us.