Access Consortium offers pipeline meetings to pharmaceutical and biotechnology companies
The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
Pipeline meetings between our regulatory authorities and pharmaceutical and biotechnology companies are an opportunity to exchange information on new developments and collaborate on new possibilities.
The meetings will also help Access regulators plan and prepare for future work-share applications.
Information discussed in these meetings will remain confidential.
Stakeholders must submit a request for a pipeline meeting.
Topics for discussion at these meetings may include:
potential candidates for Access submissions, such as
- biosimilars
- cell and gene therapies and tissue-engineered products (see Important Notice below)
- generic developments for complex technologies
- new active substance candidates for standard or priority review
requirements for future submissions involving upcoming trends, new technologies and added complexities
- for example, real world evidence, complex trials
collective indications
- for example, tropical diseases
early identification of challenges or possible technical barriers for harmonized submissions
submission strategy for novel therapeutic approaches
As the Heads of the Access Consortium, we are committed to working with our applicants to facilitate further access to safe, effective and high-quality medicines for patients.
Important Notice for Cell and Gene Therapies and Tissue-engineered Products Developers
Pipeline meetings serve as the primary entry point for engagement with Access regulators for cell and gene therapies and tissue-engineered products. The Access Consortium's Advanced Therapy Medicinal Products Working Group strongly encourages industry partners to initiate these discussions early in their development process to benefit from coordinated regulatory guidance across Access jurisdictions.
Contact us
If you are interested in a pipeline meeting, please email us at one of the addresses below. Also include a list of proposed topics, your questions and timeframes associated with your planned application. This will help us ensure we have the right staff present from the various agencies at your meeting.
Australia: streamlinedsubmission@health.gov.au
Canada: collaboration@hc-sc.gc.ca
Singapore: hsa_intl_office@hsa.gov.sg
Switzerland: networking@swissmedic.ch
United Kingdom: access-mhra@mhra.gov.uk