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GUIDANCE FOR INDUSTRY ON PREPARATION OF …

GUIDELINES ON common technical document (CTD) GUIDANCE FOR INDUSTRY . ON PREPARATION OF. common technical document FOR IMPORT. / MANUFACTURE AND MARKETING APPROVAL. OF NEW DRUGS FOR HUMAN USE. (NEW DRUG APPLICATION NDA). DRAFT GUIDANCE . This GUIDANCE documents is for feedback purpose only Comments and suggestion on this document should be submitted within 60 days of publication to CDSCO, FDA Bhavan Kotla Road, New Delhi 110002. CENTRAL DRUGS STANDARD CONTROL ORGANIZATION. DIRECTORATE GENERAL OF HEALTH SERVICES. MINISTRY OF HEALTH & FAMILY WELFARE. GOVT. OF INDIA, NOVEMBER 2010. Page 1 of 110. GUIDELINES ON common technical document (CTD) 1 ABBREVIATIONS. API Active Pharmaceutical Ingredient BA Bioavailability BE Bioequivalence CD Compact Disc CDSCO Central Drugs Standard Control Organization CPP Certificate of Pharmaceutical Product CTD common technical document FSC Free Sale Certificate GMP Good Manufacturing Practices ICH International Conference on Harmonisation ICMJE International Committee of Medical Journal Editors INR Indian National Rupee iv intravenous MA Market Au

guidelines on common technical document (ctd) 28.10.2010 page 1 of 110 guidance for industry on preparation of common technical document for import / manufacture and marketing approval

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1 GUIDELINES ON common technical document (CTD) GUIDANCE FOR INDUSTRY . ON PREPARATION OF. common technical document FOR IMPORT. / MANUFACTURE AND MARKETING APPROVAL. OF NEW DRUGS FOR HUMAN USE. (NEW DRUG APPLICATION NDA). DRAFT GUIDANCE . This GUIDANCE documents is for feedback purpose only Comments and suggestion on this document should be submitted within 60 days of publication to CDSCO, FDA Bhavan Kotla Road, New Delhi 110002. CENTRAL DRUGS STANDARD CONTROL ORGANIZATION. DIRECTORATE GENERAL OF HEALTH SERVICES. MINISTRY OF HEALTH & FAMILY WELFARE. GOVT. OF INDIA, NOVEMBER 2010. Page 1 of 110. GUIDELINES ON common technical document (CTD) 1 ABBREVIATIONS. API Active Pharmaceutical Ingredient BA Bioavailability BE Bioequivalence CD Compact Disc CDSCO Central Drugs Standard Control Organization CPP Certificate of Pharmaceutical Product CTD common technical document FSC Free Sale Certificate GMP Good Manufacturing Practices ICH International Conference on Harmonisation ICMJE International Committee of Medical Journal Editors INR Indian National Rupee iv intravenous MA Market Authorization NDA New Drug Application NRA National Regulatory Authority OCR Optical Character Recognition PD Pharmacodynamics PK Pharmacokinetics po per oral QOS Quality Overall Summary WHO World Health Organization Page 2 of 110.

2 GUIDELINES ON common technical document (CTD) 2 TABLE OF CONTENTS. 1 ABBREVIATIONS .. 2. 2 TABLE OF CONTENTS .. 3. 3 BACKGROUND .. 4. 4 SCOPE .. 6. 5 GENERAL CONSIDERATIONS .. 7. FURTHER CLARIFICATIONS .. 11. 6 GUIDELINES FOR PREPARATION OF 13. CTD: OVERVIEW .. 13. MODULE 1: GENERAL INFORMATION .. 15. MODULE 2: CTD SUMMARIES .. 20. MODULE 3: QUALITY .. 76. MODULE 4: NON-CLINICAL STUDY 94. MODULE 5: CLINICAL STUDY REPORTS .. 97. 7 ANNEXURES .. 106. ANNEXURE I: DIAGRAMMATIC REPRESENTATION OF CTD .. 106. ANNEXURE II: FORMAT FOR UNDERTAKING OR DECLARATION .. 107. ANNEXURE III: FORMAT FOR LISTING OF CLINICAL STUDIES .. 110. Page 3 of 110. GUIDELINES ON common technical document (CTD) GUIDANCE FOR INDUSTRY . ON PREPARATION OF common technical document FOR.

3 IMPORT / MANUFACTURE AND MARKETING APPROVAL OF. DRUGS FOR HUMAN USE. (NEW DRUG APPLICATION - NDA). 3 BACKGROUND. Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing of new drug by the applicant by Central Drugs Standard Control Organization (CDSCO). The regulations under Drugs and Cosmetics Rules 122A, 122B and 122D and further Appendix I, IA and VI of Schedule Y, describe the information required for approval of an application to import or manufacture of new drug for marketing. Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses.

4 Such omissions can result in unnecessary delays in approvals. Thus, a common format of submission will help in overcoming these hurdles. Through the International Conference on Harmonisation (ICH) process, the common technical document (CTD) GUIDANCE 's have been developed for Japan, European Union, and United States. Page 4 of 110. GUIDELINES ON common technical document (CTD) Most countries have adopted the CTD format. Hence, CDSCO has also decided to adopt CTD format for technical requirements for registration of pharmaceutical products for human use. The same is already in use for biological products since 2009 and now this GUIDANCE document describes the format for PREPARATION of CTD for marketing approval of pharmaceuticals for human use other than biological products (vaccines, biotechnology products, stem cell products, etc).

5 It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the PREPARATION of electronic submissions, which may happen in the near future at CDSCO. This GUIDANCE is developed by CDSCO based on The ICH Harmonised Tripartite Guideline on Organisation of the common technical document for the Registration of Pharmaceuticals for Human Use . M4, Step 4 version dated January 13, 2004, and Drugs & Cosmetics Act 1940 and Rules made thereunder. Page 5 of 110. GUIDELINES ON common technical document (CTD) 4 SCOPE. This guideline applies to import / manufacture and marketing approval of new drugs including New chemical entity, new indication, new dosage forms, modified release form, new route of administration etc.

6 Under the definition of new drug under Rule 122E of Drugs & Cosmetics rules as a finished pharmaceutical product. This guideline is not intended to advice on the design of studies that are required for product registration, but, indicates an appropriate format for submission of the data that have been acquired. Drugs & Cosmetics Act and Rules there under, defines the content requirements' for the specific type of submission and hence, this GUIDANCE document has to be read along with Drugs and Cosmetics Act 1940 and Rules made thereunder. Page 6 of 110. GUIDELINES ON common technical document (CTD) 5 GENERAL CONSIDERATIONS. The CTD is only a format for submission of information to CDSCO. It does not define the content.

7 Although adherence to overall CTD structure is necessary, it should be noted that no guideline can cover all eventualities, and common sense and a clear focus on the needs of the regulatory authority assessor are the best guides to constructing an acceptable document . Therefore, applicants can modify the format at some of the subsection levels, if needed to provide the best possible presentation of the information, in order to facilitate the understanding and evaluation. Clear and unequivocal information should be provided. Text and tables should be prepared using margins that allow the document to be printed clearly without losing any information and the left-hand margin should be sufficiently large so that information is not obscured by the method of binding.

8 You can submit documents printed on both sides of a page, however, one should take care that the information is not obscured when the page is placed in a binder. Page 7 of 110. GUIDELINES ON common technical document (CTD) Font sizes for text and tables should be of a style and size that are large enough to be easily readable. Times New Roman, 12-point font is recommended for descriptive text and Times New Roman, 9. to 10-point font for table contents and text. document Pagination and segregation: o Entire submission should never be numbered consecutively by page. Page numbering should be at the document level and not at the volume or module level. o Every document should be numbered starting at page one, except for individual literature references, where the existing journal page numbering is considered sufficient.

9 O All pages of a document should include a unique header or footer that briefly identifies its subject matter. Alternatively, a similar identifier should be used on a tab that precedes the document , to facilitate finding that document within the dossier. o If a section contains more than one document , a specific table of contents for that section can be included in the tab to identify the chronology and titles of the documents contained therein. All abbreviations should be defined at the first instance they are used and listed at the end of the dossier. References should be cited in accordance with the current edition of the uniform requirements for manuscripts submitted to biomedical journals, International Committee of Medical Journal Editors (ICMJE).

10 Page 8 of 110. GUIDELINES ON common technical document (CTD) Submission requirements / methodology o Please submit ONE hard copy and THREE soft copies Compact Disc (CD) (PDF format) of the dossier. o Hard copy: Sides and front of each volume/ file /binder must be labeled with the name of the applicant company, date of submission, name of the drug(s) and the file number (Numbering of files: x' of y' files if there are 10 files, file number 6 will be labeled as File No. 6 / 10). o Use of multiple volumes/ files/ binders is recommended than binding all the documents and modules in a very huge file. Preferably volumes/ files /binders should not be more than 3. inches thick and use of good quality binders is recommended. All the files should be kept together, bound by a good quality wire or thread (If there are too many volumes more than 10, then multiple grouping should be done).


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