Compressive Review on Role of ICH Guidelines in Registration of Pharmaceutical Products
DOI:
https://doi.org/10.22270/ajdhs.v2i3.16Keywords:
International Conference On Harmonization, Product Registration, Medicines, PharmaceuticalAbstract
The International Conference On Harmonization (ICH) Of Technical Requirements Is A Unique Project For Registration Of Pharmaceutical Products Which Are Intended For Human Use. This Brings Together The Regulatory Authorities Of Europe, Japan And United States And Experts From The Pharmaceutical Industry In The Three Regions To Discuss Scientific And Technical Aspects Of Product Registration.The Purpose Is To Make Recommendations On Ways To Achieve Greater Harmonization In The Interpretation And Application Of Technical Guidelines And Requirements For Product Registration In Order To Reduce Or Obviate The Need To Duplicate The Testing Carried Out During The Research And Development Of New Medicines.The Objective Of Such Harmonization Is A More Economical Use Of Human, Animal And Material Resources And The Elimination Of Unnecessary Delay In The Global Development And Availability Of New Medicines Whilst Maintaining Safe Guards On Quality, Safety And Efficacy And Regulatory Obligations To Protect Public Health. It Creates A Venue That Allows All Key Pharmaceutical Regulatory Authorities And Industry Stakeholders The Opportunity To Be More Actively Involved In Pharmaceutical Harmonization Work. It Aimed At The Standardization Of Requirements And Format Along With The Content Of Regulatory Documentation And Brings Down The Pressure On The Price Of Medicines By Enabling Greater Economies Of Scale And A Labelled Regulatory Playing Field. This Paper Is An Effort To Provide The Detailed Information About ICH Guidelines.
Keywords: International Conference On Harmonization, Product Registration, Medicines, Pharmaceutical
References
ICH Quality Implementation Working Group, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva: ICH Secretariat; 2011.
Meddra [Internet]. Meddra; 2019. Available From: Http://Www.Meddra.Org
Rahi S, Rana A. Role Of ICH Guidelines In Registration Of Pharmaceutical Products. International Journal Of Drug Regulatory Affairs. 2019; 7(4):14-27. https://doi.org/10.22270/ijdra.v7i4.365
Van Der Laan JW, Degeorge JJ, Editors. Global Approach In Safety Testing: ICH Guidelines Explained. Berlin: Springer; 2013. https://doi.org/10.1007/978-1-4614-5950-7
Somvanshi Y, Satbhai P. ICH Guidelines and Main Focus On Stability Guidelines For New Formulation And Dosage Forms. World J Pharm Rese. 2015; 4(10):561-78.
Pokharana M, Vaishnav R, Goyal A, Shrivastava A. Stability Testing Guidelines Of Pharmaceutical Products. Journal Of Drug Delivery And Therapeutics. 2018; 8(2):169-75. https://doi.org/10.22270/jddt.v8i2.1564
ICH Q1A (R2). Stability Testing Guidelines: Stability Testing Of New Drug Substances And Products. ICH Steeringcommittee [Internet]. London: EMEA; 2003.
Welankiwar A, Saudagar S, Kumar J, Barabde A. Photostability Testing Of Pharmaceutical Products. Int. Res. J. Pharm. 2013; 2:11-5. https://doi.org/10.7897/2230-8407.04904
Somvanshi Y, Satbhai P. ICH Guidelines and Main Focus On Stability Guidelines For New Formulation And Dosage Forms. World J Pharm Rese. 2015; 4(10):561-78.
Yadav C, Vaishnav R, Goyal A. Aspects of Pharmaceutical Process Validation: A Review. International Journal Of Pharmacy And Pharmaceutical Research. 2018; 14(1):55-66.
Validation of Analytical Procedures: Text and Methodology Q2 (R1), ICH Harmonised Tripartite Guidelines, International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use; 2005.
Ravisankar P, Navya CN, Pravallika D, Sri DN. A Review on Step-By-Step Analytical Method Validation. IOSR J Pharm. 2015; 5(10):7-19.
Romanach. R.J, Paternia AS. Theory of Sampling in Pharmaceutical Manufacturing. Impublications Com. 2015; (5):67-70. https://doi.org/10.1255/tosf.61
Chaudhari V, Yadav V, Verma P, Singh A. A Review On Good Manufacturing Practice (GMP) For Medicinal Products. Pharmatutor. 2014; 2(9):8-19.
Shukla A, Vishnoi G, Das DR. Current Good Manufacturing Guidelines For Medicinal Product. Journal Of Drug Delivery And Therapeutics. 2016; 6(2):57-61. https://doi.org/10.22270/jddt.v6i2.1201
Soni NR. Specifications For Starting Materials, Intermediates And Finished Products. Pharmatutor. 2016; 4(11):21-6.
ICH Quality Implementation Working Group, International Conference on Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. [Internet]. Geneva 20, Switzerland: ICH Secretariat; 2011.
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