Module 9 2021

23/03/2021

Procedures – not the same everywhere

EU & USA

Rest of the world

– No/limited harmonization, unclear legislation – Long review times – Unpredictable outcomes / poor transparency – Lack of resource/expertise within NRAs – Reliance upon “source country” approval, – Separate, sequential development needed But… – Rapidly evolving environment – Strong desire for education & development – Increasingly favored region in which to conduct clinical development – Developing local innovative industry, focusing particularly on biotech – More opportunity to shape environment – Growing patient/public demand for better medicine/vaccines

– Clear legislation, regulations, & guidance – Predictable timelines – Level playing field – High level of expertise available within Regulatory Authorities & Advisory Bodies But … – No guaranteed outcome – Vaccination schedule is not harmonized across EU (responsibility at national level) – Pricing/reimbursement at national level (EU) – New regulations increase demands placed upon innovator, eg, – Risk Management Plan – Medicines for Children (eg. PIP in EU) – Require ‘heavy’ post approval commitments, e.g. large phase IV studies

Diversity in capabilities

81

Guidelines relevant for nonclinical evaluation (vaccines)

1: WHO-ICH-CHMP and FDA: general

 WHO guideline on Nonclinical evaluation of vaccines; WHO TRS 927 (2005) Annex 1  Guidelines on the Nonclinical Evaluation of Adjuvanted Vaccines; WHO Adopted 2013, TRS 987 (2014) Annex 2  Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals; ICH (1997)  Guidance on Nonclinical Safety studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2); ICH, 2009  ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology- derived pharmaceuticals (ICH, CHMP 2011)  Guidelines on adjuvants in vaccines for human use; CHMP (2005)  Note for guidance on repeated dose toxicity; CHMP, 2010  Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications. FDA 2006

82

41