ICH Purpose, participants, process of

Transcript:ICH Purpose, participants, process of:
ICH Purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines INTERNATIONAL COUNCIL FOR HARMONIZATION ICH Guidelines : Inception 1990 International council for harmonization, earlier Conference Technical requirement for pharmaceuticals for human use Step to bring regulatory authorities & Pharmaceutical Industry to discuss scientific & technical aspects of drug registration Mission of ICH: To achieve greater harmonization worldwide to ensure safe, effective, high quality medicines are developed/registered in most resource & effective manner PURPOSE OF ICH GUIDELINES Registration & maintenance of Pharmaceutical product registration To have dialogues on scientific issues b/w regulatory authorities & Pharmaceutical Industry for harmonization of technical requirements of Pharm. product Contribute to public health Monitor & update harmonized technical requirements, leads to mutual acceptance of R& D data To avoid various future requirements through harmonization of selected topics Facilitate adoption of new or improved technical R&D approaches, replacing or updating current practices Implementation & integration of common standards by dissemination of the communication of information about and coordination of training on harmonized guidelines & their use To develop policy for ICH medical dictionary for regulatory activities terminology (MedDRA)- share regulatory information internationally for medicinal products Process of harmonization: 4 categories Formal ICH procedure Q & A procedure Revision procedure Maintenance procedure Business plan outlines includes costs & benefits of harmonizing topic proposed by concept paper 4 Categories of ICH topics BRIEF OVERVIEW OF QSEM Q series: Quality Guidelines are Q1A-Q1F: Stability Q2- Analytical validation Q3A-Q3D – Impurities Q4A-Q4B- Pharmacopoeias Q5A-Q5E- Quality of Biotechnological products Q-6A-Q6B- Specifications Q7 – GMP Q8 Pharmaceutical Development Q9 Quality risk management Q10- Pharmaceutical Quality System Q11 Development & Manufacture of Drug substances Q12 Life cycle Management Q13 Continuous Manufacturing of Drug substances & drug products Q14 Analytical Procedure Development S1A - S1C- Carcinogenicity studies S3A-S3B- Toxicokinetics & Pharmacokinetics S4- Toxicity testing S5 Reproductive testing S6 Biotechnological Product S7A-S7B- Pharmacology studies S8- Immunotoxicology studies S9 Non clinical evaluation of anticancer pharmaceuticals S10 Photosafety S11 Non clinical pediatric safety Safety Guidelines S Series Efficacy Guidelines E SERIES E1- Clinical safety for drugs used in long term treatment E2A-E2F- Pharmacovigilance E3 Clinical study reports E4- Dose response studies E5 Ethnic factors E6 Good clinical practice E7 Clinical Trials in Geriatric population E8 General considerations for clinical trials E9 Statistical Principles for clinical Trials E10 Choice of control group in clinical trials Efficacy Guidelines E SERIES