Table of Contents  
WEB-WISE
Year : 2015  |  Volume : 6  |  Issue : 3  |  Page : 185-187  

International conference on harmonization of technical requirements for registration of pharmaceuticals for human use


Section Editor, JPP, Government Medical College, Amritsar, Punjab, India

Date of Web Publication4-Aug-2015

Correspondence Address:
Jatinder Singh
Section Editor, JPP, Government Medical College, Amritsar, Punjab
India
Login to access the Email id

Source of Support: Nil., Conflict of Interest: There are no conflicts of interest.


DOI: 10.4103/0976-500X.162004

Rights and Permissions

How to cite this article:
Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother 2015;6:185-7

How to cite this URL:
Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother [serial online] 2015 [cited 2021 Dec 7];6:185-7. Available from: http://www.jpharmacol.com/text.asp?2015/6/3/185/162004



www.ich.org

The pharmaceutical industry is one of the largest global businesses. It is also associated with steady innovation in terms of development of new drugs and has to keep abreast of the constantly changing regulatory and technical aspects associated with the process. In addition, there are a number of ethical and economic issues ranging from safety, quality, profits, patent rights, and protection that need to be considered.

Following famous cases such as the Nazi’s experiments on concentration camp prisoners in WWII and the Tuskegee syphilis study (1932–1972), agreements for the conduct of clinical research were created. These included the 1947 Nuremberg code, the 1964 Declaration of Helsinki, and the 1979 Belmont Report. These led to the realization that it was important to have an independent evaluation of medicinal products before they are allowed on the market. This was followed by introduction of new regulations and guidelines for reporting and evaluating the data on safety, quality, and efficacy of new medicinal products in almost every country. The variance in technical requirements from country to country made it necessary to duplicate many time consuming and expensive test procedures in order to release new medicines in the international market. This resultant increase in cost of research and health care made it necessary to rationalize and harmonize regulation so as to make safe and efficacious new treatments available to patients in the minimum amount of time.

The idea of harmonization of regulatory requirements was decided by Europe, Japan, and the United States. This idea gave rise to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 1990 at a WHO conference on Drug Regulatory Authorities in Paris.

The formalization of the concept of harmonization led to immediate benefits to the regulatory authorities and the pharmaceutical industry. The ICH recommendations helped in preventing duplication of clinical trials and minimizing the use of animal testing at the same time taking care of safety and effectiveness. The recommendations also streamlined the regulatory process for new drug applications, thereby reducing the development times and optimizing resources for drug development. The ICH has since then entered the electronic era with a stress on paperless application process and sharing of real time information among the stakeholders.

The website of the ICH (http://www.ich.org) is the portal for the organizations’ activities and links information for various meetings, policies, trainings, and news.

The history of the organization and the algorithm of the harmonization process are explained in the introductory link. The Steering Committee that governs the activities of ICH consists of representatives from the founders (European Union, European Federation of Pharmaceutical Industries and Associations, Ministry of Health Labour and Welfare, Japan, Japan Pharmaceuticals Manufacturer’s Association, Food and Drug Administration, USA, Pharmaceutical Research and Manufacturers of America, Swissmedic and Health Canada). The WHO participates as an observer and International Federation of Pharmaceutical Manufacturers and Associations as a non voting member.

Work Products link to downloadable Quality, Safety, Efficacy, and Multidisciplinary guidelines. The Quality guidelines include topics relevant to good manufacturing practices (GMP) and cover diverse topics related to stability studies, analytical validation, pharmacopoeias, and quality risk management amongst others. The Safety guidelines relate to genotoxicity, reproductive toxicity, and other safety evaluations. Efficacy guidelines are comprehensive and relate to the design, conduct, safety and reporting of clinical trials. The section also includes novel medicines derived from biotechnological processes and the use of pharmacogenetics/pharmacogenomics techniques to produce better targeted medicines. The Multidisciplinary guidelines consist of ICH medical terminology (MedDRA), the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

In order to share regulatory information, ICH has formulated a standardized Medical Dictionary for Regulatory Activities (MedDRA). This is a general medical terminology that supports data analysis, communication, and data management. It is regularly updated and can be easily translated to other languages. Details are available on the sister website, www.meddra.org.

The Common Technical Document (CTD) contains the elements of quality, safety, and efficacy information in a common format. This makes the regulatory review processes simpler and allows for electronic submission. There are five modules in the CTD designed to harmonise submission of new drug applications (NDAs) in the electronic format. These have now evolved into the non proprietary Electronic Standards for the Transfer of Regulatory Information (ESTRI).

The reach of the ICH is not limited to the partner countries and training programs on regulatory and pharmacovigilance issues are conducted in many regions that have active pharmaceutical manufacturing facilities. Another initiative aimed at involving non ICH regions is the regulators forum that aims at involving various countries: Brazil, China, India and Russia, which have no formal agreement with the organization but are major clinical research hubs.

The publications link includes general documents and those related to MedDra and position papers. Surprisingly, it does not archive older publications which could be of help in understanding implementation of the guidelines.

Current advances in global pharmaceutical manufacturing involve harmonizing drug regulation. ICH guidelines reduce the expense of preparing registration dossiers and ensure improved quality, safety, and efficacy of marketed products. These initiatives are excellent value additions for the drug developers and regulatory authorities. Increased sharing of information and pharmacovigilance activities leads the consumer to repose more trust in the process. Public health in the developing countries also benefits by improved access especially to essential medicines.

The website of ICH and its content is essential reading for anyone who aims to gain an insight into regulations in drug development.





This article has been cited by
1 A Cytometrist's Guide to Coordinating and Performing Effective COVID -19 Research
Pratip K. Chattopadhyay, Andrew Filby, Evan R. Jellison, Guido Ferrari, Cherie Green, Sindhu Cherian, Jonathan Irish, Virginia Litwin
Cytometry Part A. 2021; 99(1): 11
[Pubmed] | [DOI]
2 Heavy Metals Content in Great Shearwater (Ardenna Gravis): Accumulation, Distribution and Biomarkers of Effect in Different Tissues
David Hernández-Moreno, Atocha Ramos, Cosme Damián Romay, Luis Eusebio Fidalgo, Alessandro Menozzi, Simone Bertini
Archives of Environmental Contamination and Toxicology. 2021; 80(3): 615
[Pubmed] | [DOI]
3 New Insight on the Safety of Erenumab: An Analysis of Spontaneous Reports of Adverse Events Recorded in the US Food and Drug Administration Adverse Event Reporting System Database
Maurizio Sessa, Morten Andersen
BioDrugs. 2021; 35(2): 215
[Pubmed] | [DOI]
4 Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission
Qing Zheng, Wen Liu, Yu Huang, Zhenyu Gao, Yuanhui Wu, Xiaohong Wang, Meimei Cai, Yan He, Shiju Chen, Bin Wang, Lingyu Liu, Shuqiang Chen, Hongjie Huang, Ling Zheng, Rihui Kang, Xiaohong Zeng, Jing Chen, Huaning Chen, Junmin Chen, Zhibin Li, Guixiu Shi
Rheumatology and Therapy. 2021; 8(1): 411
[Pubmed] | [DOI]
5 Should We Use Expired Drugs When Necessary?
Kenneth V. Iserson
The Journal of Emergency Medicine. 2021; 60(5): 669
[Pubmed] | [DOI]
6 Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
Tiphanie P. Vogel, Karina A. Top, Christos Karatzios, David C. Hilmers, Lorena I. Tapia, Pamela Moceri, Lisa Giovannini-Chami, Nicholas Wood, Rebecca E. Chandler, Nicola P. Klein, Elizabeth P. Schlaudecker, M. Cecilia Poli, Eyal Muscal, Flor M. Munoz
Vaccine. 2021; 39(22): 3037
[Pubmed] | [DOI]
7 Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data
Flor M. Munoz, Jakob P. Cramer, Cornelia L. Dekker, Matthew Z. Dudley, Barney S. Graham, Marc Gurwith, Barbara Law, Stanley Perlman, Fernando P. Polack, Jonathan M. Spergel, Eva Van Braeckel, Brian J. Ward, Arnaud M. Didierlaurent, Paul Henri Lambert
Vaccine. 2021; 39(22): 3053
[Pubmed] | [DOI]
8 A phase 2a randomized clinical trial of intravenous vedolizumab for the treatment of steroid-refractory intestinal acute graft-versus-host disease
Yngvar Fløisand, Mark A. Schroeder, Patrice Chevallier, Dominik Selleslag, Steven Devine, Anne S. Renteria, Mohamad Mohty, Ibrahim Yakoub-Agha, Chunlin Chen, Andrejus Parfionovas, Syed Quadri, Johan Jansson, Mona Akbari, Yi-Bin Chen
Bone Marrow Transplantation. 2021; 56(10): 2477
[Pubmed] | [DOI]
9 Pharmaceutical industry in export marketing: a closer look at competitiveness
Mehdi Mohammadzadeh, Nima Bakhtiari, Reza Safarey, Tayebeh Ghari
International Journal of Pharmaceutical and Healthcare Marketing. 2021; 13(3): 331
[Pubmed] | [DOI]
10 Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomised, double-blinded, placebo-controlled trial
Carlos A. Batagello, Fabio C. Vicentini, Manoj Monga, Aaron W. Miller, Giovanni S. Marchini, Fabio C.M. Torricelli, Alexandre Danilovic, Rafael F. Coelho, Miguel Srougi, Willian C. Nahas, Eduardo Mazzucchi
BJU International. 2021;
[Pubmed] | [DOI]
11 Pharmacokinetic, efficacy and safety evaluation of B-domain-deleted recombinant FVIII (SCT800) for prophylactic treatment in adolescent and adult patients with severe haemophilia A
Feng Xue, Xielan Zhao, Jing Sun, Xiaojing Zeng, Fenge Yang, Ming Xu, Ziqiang Yu, Weiying Gu, Ying Feng, Wenqian Li, Changcheng Zheng, Hui Bi, Liangzhi Xie, Wenlin Gai, Renchi Yang
Haemophilia. 2021; 27(5): 814
[Pubmed] | [DOI]
12 Electrochemistry and Determination of an Antiviral Drug at Ionic Liquids Crystals-Carbon Nanotubes Modified Glassy Carbon Electrode
Ahmed Galal, Yousef M. Ahmed, Mansour H. M. Ahmed, Nada F. Atta
Journal of The Electrochemical Society. 2021; 168(11): 116512
[Pubmed] | [DOI]
13 Knowledge, attitudes and practices pertaining to urogenital schistosomiasis in Lambaréné and surrounding areas, Gabon
Jean Claude Dejon-Agobé, Jeannot Fréjus Zinsou, Yabo Josiane Honkpehedji, Jean Ronald Edoa, Bayodé Roméo Adegbité, Romuald Beh-Mba, Peter Gottfried Kremsner, Ayola Akim Adegnika, Martin Peter Grobusch
Parasites & Vectors. 2021; 14(1)
[Pubmed] | [DOI]
14 Antifungal and Antibiofilm Activities of B-Type Oligomeric Procyanidins From Commiphora leptophloeos Used Alone or in Combination With Fluconazole Against Candida spp.
Renato Dantas-Medeiros, Ana Caroline Zanatta, Luanda Bárbara Ferreira Canário de Souza, Júlia Morais Fernandes, Bruno Amorim-Carmo, Manoela Torres-Rêgo, Matheus de Freitas Fernandes-Pedrosa, Wagner Vilegas, Thiago Antonio de Sousa Araújo, Sylvie Michel, Raphaël Grougnet, Guilherme Maranhão Chaves, Silvana Maria Zucolotto
Frontiers in Microbiology. 2021; 12
[Pubmed] | [DOI]
15 A Step-by-Step Approach to Improve Clinical Translation of Liposome-Based Nanomaterials, a Focus on Innate Immune and Inflammatory Responses
Giacomo Della Camera, Dorelia Lipsa, Dora Mehn, Paola Italiani, Diana Boraschi, Sabrina Gioria
International Journal of Molecular Sciences. 2021; 22(2): 820
[Pubmed] | [DOI]
16 In Vitro Culture of Rosmarinus officinalis L. in a Temporary Immersion System: Influence of Two Phytohormones on Plant Growth and Carnosol Production
Eder Villegas-Sánchez, Mariana Macías-Alonso, Soraya Osegueda-Robles, Lisset Herrera-Isidrón, Hector Nuñez-Palenius, Joaquín González-Marrero
Pharmaceuticals. 2021; 14(8): 747
[Pubmed] | [DOI]
17 Correlation of Chillies Capsaicinoids Contents with their Cytotoxic Effects against Hepatocarcinoma Cells
Alaadin E. El-Hadd, Ahmed S. Saad, Soad Z. El-Emam, Asmaa A. Amer
Pakistan Journal of Biological Sciences. 2021; 24(2): 219
[Pubmed] | [DOI]
18 Human ADME for YH12852 using wavelength scanning cavity ring-down spectroscopy (WS-CRDS) after a low radioactivity dose
Anhye Kim, Stephen R Dueker, Feng Dong, Ad F Roffel, Sang-won Lee, Howard Lee
Bioanalysis. 2020; 12(2): 87
[Pubmed] | [DOI]
19 New Analytical Method for Simultaneous Analysis of Losartan and E-3174 by HPLC in Human Plasma: Application in Pharmaceutical Science
Edgar Alejandro de Leon-Diaz de Leon, Antonio Gordillo-Moscoso, Úrsula Medina, Ángel Antonio Vertiz Hernández, Rafael Almendra-Pegueros, Juan M. López Quijano
Current Analytical Chemistry. 2020; 16(8): 979
[Pubmed] | [DOI]
20 International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale
Katrina Abuabara, Jonathan I Silverberg, Eric L Simpson, Amy S Paller, Lawrence F. Eichenfield, Robert Bissonnette, James Krueger, John E. Harris, Laura Dalfonso, Stephanie E Watkins, Julie M Crawford, D Thaçi, Emma Guttman-Yassky
BMJ Open. 2020; 10(11): e039928
[Pubmed] | [DOI]
21 A Review on Mixing-Induced Protein Particle Formation: The Puzzle of Bottom-Mounted Mixers
Benson Gikanga, Yuh-Fun Maa
Journal of Pharmaceutical Sciences. 2020; 109(8): 2363
[Pubmed] | [DOI]
22 A Pharmacokinetic Study by LC-MS/MS to Quantify Isoquercetin and Astragalin in Rat Serum After Oral Administration of a Combined Extract of Moringa oleifera and Centella asiatica
Mohd Salleh Rofiee, Mohd Izwan Mohamad Yusof, Teh Lay Kek, Mohd Zaki Salleh
Revista Brasileira de Farmacognosia. 2020; 30(6): 804
[Pubmed] | [DOI]
23 In vitro high-throughput drug sensitivity screening with patient-derived primary cells as a guide for clinical practice in hepatocellular carcinoma—A retrospective evaluation
Jinghe Li, Xiu Xiong, Zuo Wang, Yufei Zhao, Zhengrong Shi, Ming Zhao, Tao Ren
Clinics and Research in Hepatology and Gastroenterology. 2020; 44(5): 699
[Pubmed] | [DOI]
24 Analysis of granulation mechanism in a high-shear wet granulation method using near-infrared spectroscopy and stirring power consumption
Keita Koyanagi, Akinori Ueno, Yusuke Hattori, Tetsuo Sasaki, Tomoaki Sakamoto, Makoto Otsuka
Colloid and Polymer Science. 2020; 298(8): 977
[Pubmed] | [DOI]
25 The Italian multicenter experience with edaravone in amyotrophic lateral sclerosis
Christian Lunetta, Cristina Moglia, Andrea Lizio, Claudia Caponnetto, Raffaele Dubbioso, Fabio Giannini, Sabrina Matà, Letizia Mazzini, Mario Sabatelli, Gabriele Siciliano, Isabella Laura Simone, Gianni Sorarù, Antonella Toriello, Francesca Trojsi, Marcella Vedovello, Fabrizio D’Ovidio, Massimo Filippi, Andrea Calvo
Journal of Neurology. 2020; 267(11): 3258
[Pubmed] | [DOI]
26 Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey
Minji Sohn, Yun-Kyoung Song, Ah Young Jeon, Jung Mi Oh, In-Wha Kim
Korean Journal of Clinical Pharmacy. 2019; 29(4): 267
[Pubmed] | [DOI]
27 Schistosoma haematobium infection morbidity, praziquantel effectiveness and reinfection rate among children and young adults in Gabon
Jean Claude Dejon-Agobé, Jean Ronald Edoa, Yabo Josiane Honkpehedji, Jeannot Fréjus Zinsou, Bayodé Roméo Adégbitè, Mirabeau Mbong Ngwese, Ance Mangaboula, Bertrand Lell, Tamirat Gebru Woldearegai, Martin Peter Grobusch, Benjamin Mordmüller, Ayôla Akim Adegnika
Parasites & Vectors. 2019; 12(1)
[Pubmed] | [DOI]
28 Quantitative 1H-NMR Spectroscopy for Profiling Primary Metabolites in Mulberry Leaves
Qianqian Liang,Qiuying Wang,Yuan Wang,Ya-nan Wang,Jia Hao,Miaomiao Jiang
Molecules. 2018; 23(3): 554
[Pubmed] | [DOI]
29 Serum S100B Levels Can Predict Computed Tomography Findings in Paediatric Patients with Mild Head Injury
Fatos M. Kelmendi,Arsim A. Morina,Agon Y. Mekaj,Afrim Blyta,Ridvan Alimehmeti,Shefki Dragusha,Feti Ahmeti,Qamile Morina,Afrim Kotori
BioMed Research International. 2018; 2018: 1
[Pubmed] | [DOI]
30 Adverse drug event profile associated with pregabalin among patients with and without cancer: analysis of a spontaneous reporting database
Eiji Kose
Journal of Clinical Pharmacy and Therapeutics. 2018;
[Pubmed] | [DOI]
31 Surveillance of drugs that most frequently induce acute kidney injury: A pharmacovigilance approach
Keiko Hosohata,Ayaka Inada,Saki Oyama,Daisuke Furushima,Hiroshi Yamada,Kazunori Iwanaga
Journal of Clinical Pharmacy and Therapeutics. 2018;
[Pubmed] | [DOI]
32 Orthogonal Separations in Reversed-Phase Chromatography
Roopali Agrawal,Sateesh Belemkar,Chandrakant Bonde
Chromatographia. 2018; 81(4): 565
[Pubmed] | [DOI]
33 Development and validation of a robust analytical method to quantify both etoposide and prodigiosin in polymeric nanoparticles by reverse-phase high-performance liquid chromatography
M. M. Agwa,F. M. Elessawy,A. Hussein,M. A. El Demellawy,A. O. Elzoghby,M. H. Abd El-Salam,A. I. Eldiwany
Analytical Methods. 2018; 10(19): 2272
[Pubmed] | [DOI]
34 Adherence reporting in clinical trials of type 2 Diabetes Metellius in the field of Traditional Chinese Medicine
Xing Dongmei,Zhang Junhua,Zhu Mingjun,Zhao Yu,Shang Hongcai
Journal of Traditional Chinese Medicine. 2017; 37(1): 140
[Pubmed] | [DOI]
35 Capillary electrophoresis with online stacking in combination with [email protected] reinforced hollow fiber solid-liquid phase microextraction for quantitative analysis of Capecitabine and its main metabolite 5-Fluorouracil in plasma samples isolated from cancer patients
Mehrdad Forough,Khalil Farhadi,Rahim Molaei,Hedayat Khalili,Ramin Shakeri,Asghar Zamani,Amir Abbas Matin
Journal of Chromatography B. 2017; 1040: 22
[Pubmed] | [DOI]
36 TRIPS and disclosure of clinical information: An intellectual property perspective on data sharing
Gabriele Spina Alì
The Journal of World Intellectual Property. 2017;
[Pubmed] | [DOI]
37 Building Capability for Clinical Pharmacology Research in Sub-Saharan Africa
MM Gutierrez,G Pillai,S Felix,F Romero,KO Onyango,S Owusu-Agyei,KP Asante,KI Barnes,P Sinxadi,E Allen,S Abdulla,C Masimirembwa,M Munyoro,G Yimer,T Gebre-Mariam,J Spector,B Ogutu
Clinical Pharmacology & Therapeutics. 2017;
[Pubmed] | [DOI]
38 The Occurrence of Zearalenone in South Korean Feedstuffs between 2009 and 2016
Hansub Chang,Woori Kim,Ju-Hee Park,Dongho Kim,Choong-Ryeol Kim,Soohyun Chung,Chan Lee
Toxins. 2017; 9(7): 223
[Pubmed] | [DOI]
39 A Decrease of Incidence Cases of Fumonisins in South Korean Feedstuff between 2011 and 2016
Juhee Park,Hansub Chang,Seungran Hong,Dongho Kim,Soohyun Chung,Chan Lee
Toxins. 2017; 9(9): 286
[Pubmed] | [DOI]
40 Reducing head computed tomography after mild traumatic brain injury: Screening value of clinical findings and S100B protein levels
Shadi Asadollahi,Kamran Heidari,Mehrdad Taghizadeh,Arash Mohammad Seidabadi,Morteza Jamshidian,Ali Vafaee,Mohammad Manoochehri,Ali Habibzade Shojaee,Hamid Reza Hatamabadi
Brain Injury. 2016; 30(2): 172
[Pubmed] | [DOI]
41 An Overview of Pharmaceutical Excipients: Safe or Not Safe?
Cátia G. Abrantes,Dinah Duarte,Catarina P. Reis
Journal of Pharmaceutical Sciences. 2016; 105(7): 2019
[Pubmed] | [DOI]



 

Top
  
 
  Search
 
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

 
  In this article

 Article Access Statistics
    Viewed4239    
    Printed62    
    Emailed0    
    PDF Downloaded613    
    Comments [Add]    
    Cited by others 41    

Recommend this journal