ICH GUIDELINES

Nicely described regarding about the overview of ICH guidelines as per PCI syllabus specially for Pharmacy students not only for pharmacy student for all. It include Quality, Safety, Efficacy & Multidisciplinary guidelines and also include Common Technical Document & Electronic Common Technical Document.

1. BHARAT PHARMACEUTICAL TECHNOLOGY TOPIC: OVERVIEW OF ICH GUIDELINES PREPARED BY Name:- Bishal Bhattacharjee Stream:- B.Pharm Year:- 4 th year/ Final year Sem :- 7 th sem

2. CONTENTS Introduction Objective of ICH QSEM guidelines Common Technical Document Organization & Advantages of Common Technical Document Silent benefits & Limitations of Common Technical Document Electronic Common Technical Document Benefits & Advantages of Electronic Common Technical Document

3. INTRODUCTION The International Council for Harmonization(ICH) of technical requirements for pharmaceuticals of human use brings together the medicines regulatory authorities and pharmaceutical industry around the world. ICH is a joint initiative involving both regulators and research based industry representatives of the European Union, Japan and the US in scientific and technical discussions of the testing procedures required assess and ensure safety, quality and efficacy of medicines.

4. OBJECTIVE OF ICH To increase international harmonization of technical requirements to ensure safe, effective and high quality medicines are developed. To harmonize technical requirements for registration or marketing approval. To promote public health. To prevent unnecessary duplication of clinical trials on humans. To minimize the use of animal testing without compromising safety and effectiveness of drug.

5. QSEM GUIDELINES Q: Quality guidelines- It includes stability, impurities, testing and GMP S: Safety guidelines- It include carcinogenicity, genotoxicity , reprotoxicity . E: Efficacy guidelines- It includes clinical pharmacy genomics. M: Multidisciplinary guidelines- It includes medical dictionary or regulatory activities, electric standard on clinical safety studies, common technical document.

6. COMMON TECHNICAL DOCUMENT(CTD) CTD is an internationally agreed “well structured common format” for the organization of the technical requirements that is to be submitted to the regulatory authority as an application for the registration of pharmaceuticals for human use in all three ICH regions: European Medicines Agency(EMEA, Europe) Food & Drug Administration(FDA, USA) Ministry of health, labor & welfare(MHLW, Japan) In July 2003, the CTD became the mandatory format for new drug application in the EU & Japan and the strongly recommended format of choice for NDAs submitted to the FDA. It has been adopted by several other countries including Australia, Canada & Switzerland(2004).

7. ORGANIZATION OF CTD It is organized into: Module A: General Information Module B: CTD summaries Module C: Quality Module D: Nonclinical study reports Module E: Clinical study reports ADVANTAGES OF CTD To save time and resources To facility regulatory review and communications Appropriate for the data Easy to understand and evaluation of data

8. SILENT BENEFITS OF CTD More "reviewable” applications Complete, well-organized submissions More predictable format Easier exchange of information Easier analysis across applications LIMITATIONS OF CTD CTD is only a format, its not a single dossier with a single content Legal requirements differ in the different regions Pharmacopoeias are not harmonized Applicant may have regional preferences ICH guidelines have not yet harmonized in all requirements

9. ELECTRONIC COMMON TECHNICAL DOCUMENT The electronic Common Technical Document(eCTD) is an interface and international specification for the Pharmaceutical Industry to agency transfer of regulatory information. The specification is based on the Common Technical Document(CTD) format and was developed by the International Council for harmonisation (ICH). The eCTD allows submission builders to map to documents within and across all submissions and applications. This feature can save time and money, but only if it is set up and handled effectively from the beginning of the product IND application.

10. BENEFITS OF eCTD Reusable content Better document management Metadata corrections Better life-cycle capabilities ADVANTAGE OF eCTD Reviewers are already familiar with the content and document standards Local affiliates can review updates in real-time Handling, managing & archiving trial and document essential information is less time-consuming Documents are easily accessible via search & tracking

11. THANK YOU