Governmental and non-governmental activities of interest to the RICC
The Governmental and non-governmental activities of interest to the RICC provides a list of website links to government and non-government activities that are relevant to the RICC.
At this stage, a simple title and hyperlink is provided although it is intended in the future that a short description will be developed for each of these links. While we endeavour to keep the list current and complete, the information has necessarily been compiled in a non-systematic fashion. If you are aware of activities that are relevant but have not been included in this list we would be grateful if you could let the RICC Repository Manager know so that the appropriate information can be uploaded. If your organisation has been included on the list but you would prefer alternative information presented please also contact us.
Governmental / Agency links and information relating to HTA-Regulatory Interactions by region
- Government of Canada HC (2007) Progressive Licensing – Drugs and Health Products – Health Canada.
- pre-NOC review (parallel processing with regulatory licensing) for drugs undergoing the Common Drug Review process
- Health Technology Exchange (HTX), Ontario. ‘Harmony Project’ In collaboration with MaRS EXCITE aims to develop a process and related content to assist medtech companies in addressing regulatory, reimbursement and HTA evidentiary requirements for multiple jurisdictions and payers.
European – EMA
- Working with HTA bodies at the EMA, EMA overview,
- Early dialogue between regulators and health technology assessment bodies key to medicines development (2013) EMA overview,
- European Medicines Agency and EUnetHTA Joint Action start collaboration on European Public Assessment Report (EPAR) contribution to relative effectiveness assessments
- European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development (2013)
- Draft EMA best practice guidelines for pilot EMA HTA parallel scientific advice procedures (May 2014) public consultation,
- EMA Adaptive Pathways (formerly Adaptive Licensing) Pilot
European – HTA Network and EUnetHTA
- EMA-EUnetHTA 3-year Work Plan (2013), EUnetHTA EMA co-publication, 3p
- Minutes from the EUnetHTA / EMA meetings since 2010
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
The ENCePP-HTA working group is a multidisciplinary and multi-stakeholder working group within ENCePP with the mission of capacity building for the conduct of post authorization studies required by both regulatory and HTA bodies, as well as the development of methods related to the conduct of such studies in case they do not exist.
- Mandate of ENCePP Working Group on Health Technology Assessment (HTA)
- ENCePP HTA WG review draft delegated act on Post Authorization Efficacy Studies (PAES)
European – SEED (hosted by HAS)
- Joint scientific advice meetings between the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA)
- Voluntary parallel scientific advice with the MHRA and NICE,
- Early Access to Medicines Scheme (MHRA with NICE involvement)
- NICE Decision Support Unit report on Managed Entry Agreements (MEAs) -Jan 2016
- Memorandum of understanding between FDA and CMS (2012)
- Federal Register Notice: Pilot Program for Parallel Review of Medical Products (2011)
- Federal Register: Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program (2011)
- CMS: Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decisions (2012)
- Miller R (2014) Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test, “The Grey Sheet”, August 13, Article #29140813003
- FDA Approves first non-invasive DNA screening test for colorectal cancer: collaboration with CMS contributed to proposed Medicare coverage (2014)
- FDA invitation to private coverage bodies to participate in pre-submission meetings for devices
Non-governmental organisations involved in HTA-Regulatory Interactions
CASMI (Centre for the Advancement of Sustainable Medical Innovation)
CIRS (Centre for Innovation in Regulatory Science)
- Cone & Lisinski (2008) Regulation and Reimbursement: Two sides of the same coin? Workshop Report, The Centre for Innovation in Regulatory Science (CIRS). 28 p.
- Pichler et al (2010) Review and Reimbursement: Aligning the needs and requirements in clinical development; Workshop Report, The Centre for Innovation in Regulatory Science (CIRS). 44p
- Pichler et al (2011) Evidentiary requirements in clinical development: Synchronising phase 3 requirements to meet multiple needs. Workshop Report, The Centre for Innovation in Regulatory Science (CIRS). 39 p
CMTP (Centre for Medical Technology Policy)
- Green Park Collaborative homepage, CMTP
- Oncology Consortium: Developing methodological standards for comparative effectiveness research in oncology, Green Park Collaborative USA, 2p
- Endocrine-metabolic consortium: Developing methodological standards for comparative effectiveness research in endocrine and metabolic diseases, Green Park Collaborative USA, 2p
- Promoting Better Decisions Using Real World Evidence, Green Park Collaborative USA
IMI (Innovative Medicines Initiative, an EU Public-Private partnership)
- GETREAL: Incorporating real-life clinical data into drug development,
- IMI-2 4th Call for Proposals (17th December 2014): Enabling Platform on Medicines Adaptive Pathways to Patients:
- ADAPT-SMART: Accelerated Development of Appropriate Patient Therapies a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes
MIT Center for Biomedical Innovation: NEWDIGS
A multi-stakeholder initiative to explore Adaptive Licensing (AL) and Medicines Adaptive Pathways to Patients (MAPPs) with the ultimate goal of more reliably and sustainably delivering new, better, affordable therapeutics to the right patients faster.
- Multi-stakeholder Drug Development Pilots Stakeholders work together to improve drug development, Tapestry Networks
- Pilots of multi-country, multi-stakeholder consultations in drug development: promoting clarity on sources of medicinal value (2011) European Healthcare Innovation Leadership Network, Tapestry Networks. 27p.