Comments (in chronological order):
Comment by IQWiG on the draft bill of the Federal Ministry of Health for a regulation on the procedural principles for the assessment of examination and treatment methods in outpatient health care services reimbursed by statutory health insurance and in hospitals (Regulation on the Procedure for the Assessment of Methods - MBVerfV) (German version)
All clinical trial data on Covid-19 medicines and vaccines should be published on the day of marketing authorisation! Open letter to the European Medicines Agency
IQWiG comment on the draft bill of the Federal Ministry of Health for a regulation on the procedure and requirements for testing the eligibility for reimbursement of digital health applications in statutory health insurance (Digitale-Gesundheitsanwendungen-Verordnung, DiGAV [Digital Health Applications Regulation]) (German Version)
Joint open letter on access to clinical study reports
Comments on 'Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses' (EMA/CHMP/SAWP/291384/2019)
Comments from IQWiG on 'Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations' (EMA/763513/2018)
IQWiG's comment on the Federal Government's draft for a law on the establishment of the German Implant Registry and further amendments to Social Code Book V (Implant Registry Establishment Act - EIRD) (German version)
Comment by IQWiG on the draft by the Federal Ministry of Health (BMG) on a law for better health care through digitalization and innovation (Digital Health Care Act - DVG) (German Version)
Stellungnahme des IQWiG zum Gesetzentwurf der Bundesregierung zum Entwurf eines Gesetzes für mehr Sicherheit in der Arzneimittelversorgung (GSAV) (German Version)
Comments from IQWiG on 'Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders' (CHMP/EWP/566/98 Rev.3)
How the European Medicines Agency engages with medicine producers before they apply for authorisations to market their medicines in the EU - omments within the European Ombudsman’s inquiry OI/7/2017/KR - Public consultation
Comments from IQWiG on the draft legislation by the Federal Ministry of Health – draft of a law for more safety in drug supply (GSAV) (German Version)
Comments from IQWiG on the Consultation Document on ‘Good Clinical Practice for Advanced Therapy Medicinal Products 01/2018‘
Comments from IQWiG on 'ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials' (EMA/CHMP/ICH/436221/2017)
Comments from IQWiG on 'Reflection paper on the use of extrapolation in the development of medicines for paediatrics' (EMA/199678/2016)
Comment from IQWiG on the draft law of the Federal Government - Draft law to promote the provision of pharmaceutical care in statutory health insurance (German)
Comments on the Guideline on evaluation of anticancer medicinal products in man – Draft ' (EMA/CHMP/205/95 Rev.5)
Stellungnahme des IQWiG zum Referentenentwurf des Bundesministeriums für Gesundheit - Entwurf eines Gesetzes zur Stärkung der Arzneimittelversorgung in der GKV (German)
Comments on WHO Working Document QAS/16.664: WHO Global Model Regulatory Framework for Medical Devices including IVDs
Offener Brief des IQWiG zur Empfehlung des Senats der Leibniz-Gemeinschaft, die Förderung der ZB MED durch Bund und Länder zu beenden (German)
Comments on 'Concept paper on the need to revise the “Guideline on the 4 evaluation of anticancer edicinal products in man” in order to provide guidance on the reporting of safety data from clinical trials' (EMA/CHMP/292464/2014)
Comments on draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited (EMA/42176/2014)”
Comment on "Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies - Draft"
Comment on WHO Statement on Public Disclosure of Clinical Trial Results
IQWiG comments on EMA’s policy on the publication of clinical study reports
Comment on the draft law of the Federal Government for an act to promote the provision of health care in statutory health insurance (Statutory Health Insurance [SHI] Act to Promote Health Care - GKV-VSG) (German version)
Joint statement from IQWiG, GMDS and IBS-DR: "Application of prediction intervals in meta-analyses with random effects"
IQWiG comment on the draft law of the Federal Government for advancing cancer screening and quality assurance using clinical cancer registries (Law on Cancer Screening and Registration – KFRG) Bundestag printed paper 17/11267 of 05.12.2012 (German version)
Comment to AHRQ on: "Assessing confounding, the risk of bias and precision of observational studies of interventions or exposures: further development of the RTI Item Bank"
Comment to AHRQ on: "A framework for assessing the strength of methodological recommendations for systematic review and meta-analysis"
Comment on the proposal of the EU commission for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (German version)
Comment on the draft of a law to implement the recommendations of the National Cancer Plan (Cancer Plan Implementation Law) (German version)
IQWiG comment on the public hearing of the German Bundestag’s Committee on Health “Better guarantee of safety, efficacy and health benefit of medical devices”, Bundestag printed paper 17/8920, and “More safety for medical devices”, Bundestag printed paper 17/9932 (German version)
Comment on the draft of a second law to Change Legislation on Medicinal Products and Other Regulations. (16th Amendment to the Medicinal Products Act [AMG]) (German version)
Joint statement from IQWiG, GMDS and IBS-DR: "Importance of results from indirect comparisons"
Comment on the draft of the Second law to Change Legislation on Medicinal Products and Other Regulations (16th Amendment to the AMG) (German version)