SASAT (South Asian Society on Atherosclerosis & Thrombosis) Proposal for Regulatory Guidelines for Generic Low-molecular Weight Heparins (LMWHs)

Directive 2001/83/EC, as amended.

Guideline on similar biological medicinal products (CHMP/437/04/draft).

Guideline on clinical investigation of medicinal products for prophylaxis of high intra and postoperative venous thromboembolic risk (CPMP/EWP/707/98 Rev. 1 - draft).

Concept paper on similar biological medicinal products containing low-molecular weight heparins-(non) clinical issues.

Note for guidance on toxicokinetics: a Guidance for assessing systemic exposure in toxicological studies (CPMP/ICH/384/95).

Note for guidance on nonclinical locale tolerance testing of medicinal products (CPMP/SWP/2145/00).

Guideline on risk management systems for medicinal products for human use (EMEA/CHMP 96286/2005).

Note for Guidance on good clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95).

Harenberg, J. , Kakkar, A. , Bergqvist, D. , Barrowcliffe, T. , Casu, B. , Fareed, J. , Holmer, E. , Mismetti, P. , Ofuso, F. , Raake, W. , Sammama, M. , Schulman, S. Bio-similar low-molecular weight heparins of the Scientific Subcommittee on Anticoagulation of the International Society of Thrombosis and Haemostasis. In Press.