The Evolution of ICH Shift From Input to
- Slides: 25
The Evolution of ICH Shift From Input to Output-The Influence of the CTD Justina A. Molzon, MS Pharm, JD Associate Director for International Programs Center for Drug Evaluation and Research US Food and Drug Administration 1
Topics for Discussion • Shift in focus of ICH from input by industry to output by regulators • The influence of the CTD and e. CTD in making this shift possible • The link between the CTD/e. CTD, Good Review Practices and e. Review Initiatives • The global ramifications on review and sharing of information between drug regulatory authorities
Information Flow Shift in Center of Gravity ICH Guidelines CTD REVIEW Initial Current
ICH and the CTD
ICH INTERNATIONAL CONFERENCE ON HARMONIS/ZATION of Technical Requirements for the Registration of Pharmaceuticals for Human Use http: //www. ich. org Hosted by ICH Secretariat IFPMA-Geneva, Switzerland
A Unique Approach • ICH was created in 1990 • Agreement between the EU, Japan and the USA to harmonize different regional requirements for registration of pharmaceutical drug products – Canada, EFTA and WHO participate in ICH as observers • Unique because joint effort by regulators and associated pharmaceutical industry trade associations • Pharmaceutical industry aware of areas of disharmony in regulatory submission requirements
ICH Harmonized Guidelines • • Efficacy - 15 topic headings/16 guidelines Safety - 8 topic headings/16 guidelines Quality - 10 topic headings/24 guidelines Multidisciplinary (Regulatory Communications) – Medical Dictionary - Med. DRA – Electronic Standards - ESTRI, E 2 B • In 1996 ICH industry representatives proposed assembling the information generated by these harmonized guidances in the same order • Goal was to decrease the amount of time and staff needed to assemble and disassemble documents for submission to ICH regions
Regulators • Initially the ICH regulators were resistant to change established submission formats • Felt it would be too disruptive to the review process • Needed to be convinced there was value in a harmonized submission format • Requested a resource and feasibility study 9
Industry Resource Survey • Conducted in May 1996 • Evaluated the number of weeks to convert an NDA into an EMEA submission (and the reverse) • Evaluated the number and types of staff required for the conversion
Survey Results Months Conversion Times Company
Survey Results Number of Staff Needed to Convert
Realization • Lots of time and energy to rearrange paper from one ICH region submission format to another • Caused a delay of submission to that ICH region • Resulted in a delayed access to new innovative medicines for patients in that region 13
ICH CTD Module 1 Module 2 1. 0 Regional Administrative Information 1. 1 To. C of Module 1 or overall To. C, including Module 1 1. 0 2. 1 To. C of the CTD (Mod 2, 3, 4, 5) 2. 1 2. 2 Introduction 2. 2 2. 3 Quality Overall Summary 2. 4 2. 5 2. 3 2. 6 Module 3 Quality 3. 0 2. 7 2. 4 Nonclinical Overview 2. 5 Clinical Overview 2. 6 Nonclinical Summary 2. 7 Clinical Summary Module 5 Clinical Nonclinical Source: ICH Implementation Coordination Group Study Reports 5. 0 4. 0 14 Module 4
Benefits of the CTD—FDA Perspective • More reviewable applications – More logical order of presentation – Follows development scheme • • • More predictable format More consistent reviews Easier analysis across applications Easier exchange of information Facilitates electronic submissions
Electronic Submissions The equivalent of 50, 000 paper pages of data. .
Electronic Submission Receipt FDA Gateway System creates submission record & notifies document room. (Submission identified by Document ID) Sponsor Document control clerk completes coding, assigns review staff, notifies Project Manager DARRTS ASR COMIS ECH Submission received at Gateway (ESG), Sponsor notified EDR CDER Inbound ASR e-mails Project Manager If validation fails, ASR emails Document room for manual handling. 18
Electronic Submission Gateway • Critical to improving efficiency • Gets submission material to the reviewer in an expedited manner • Introduces automation into FDA processes – Use of electronically filable forms key • Promotes paperless review • Electronic review tools for reviewers
e. CTD Format Flows Through the Review Process ICH CTD Guidelines e. Review Easier to Develop Standardized Reviewer e. Templates Promotes e. Submission and e. Review tools
Guidance to Industry Good Review Practices • What we believe we should do in a review is closely tied to what data we want a sponsor to submit • As a result there will be considerable similarity between guidance to industry and what we consider Good Review Practices • Because ICH Regions have harmonized much of the information submitted for marketing authorization, ICH regulators could trend towards similar review practices
Transparency and Consistent Review Process • Because of the complexity of disciplines and specialties involved in the review process, a consistent approach to evaluating submissions and expressing conclusions is needed • Should represent agreed upon best practices-Good Review Practices (GRPs) • Having a common style and review format will help drug regulatory authority staff, industry and the public understand the review process from data to interpretation, to recommendations and decisions and subsequent regulatory actions
Summary • The CTD format of a submission influences the content of a review by imposing a consistent order of information and data provided • The CTD shapes both the conduct of the review and the presentation of the results of the review • Consistency of CTD format should promote consistent review practices leading to GRPs • As more countries utilize ICH guidelines and the CTD, a common regulatory language will evolve promoting greater interaction between drug regulatory authorities
Thank you for your attention 25
- Ich freue mich wenn ich dich seh ich finde dich so nett
- Difference between arithmetic shift and logical shift
- Bathochromic shift and hypsochromic shift
- Difference between arithmetic shift and logical shift
- Homocyclic diene component
- Difference between arithmetic shift and logical shift
- Movement of mandible muscles
- Bathochromic shift and hypsochromic shift
- Logical shift and arithmetic shift
- Cap 221
- Ulla hahn sehnsucht 1945
- Ich tempo je vražedné
- Passwortgeschützte buchstabensuppe
- Ich kenne dich nicht aber ich mag dich
- Berikut ini perangkat output komputer adalah...
- Characteristics of natural approach
- Vẽ hình chiếu vuông góc của vật thể sau
- Công thức tính thế năng
- Thế nào là mạng điện lắp đặt kiểu nổi
- Tỉ lệ cơ thể trẻ em
- Lời thề hippocrates
- Vẽ hình chiếu đứng bằng cạnh của vật thể
- Quá trình desamine hóa có thể tạo ra
- Các môn thể thao bắt đầu bằng tiếng nhảy
- Hát kết hợp bộ gõ cơ thể
- Khi nào hổ con có thể sống độc lập