REGISTRATION DOSSIER OF PHARMACEUTICALS

 

Section A:    Table of Contents

Section B:    Nonclinical overview

  • Overview of the Nonclinical Testing Strategy
  • Pharmacology
  • Pharmacokinetics
  • Toxicology
  • Integrated Overview and Conclusions
  • List of Literature Citations

Section C:    Nonclinical written and tabulated summaries
1.    Introduction

2. Content of nonclinical written and tabulated summaries

  • Pharmacology
  • Pharmacokinetics
  • Toxicology

Section D: Nonclinical study reports

Part IV Clinical Document
Part IV should provide the Clinical Overview and the Clinical Summary. The document of this part is not required for Generic Products, Minor Variation Products and some Major Variation Products. For ASEAN member countries, the Study Reports of this part may not be required for NCE, Biotechnological Products and other Major Variation Products if the Original Products are already registered and approved for market authorization in Reference Countries.

Section A. Table of contents

Section B. Clinical overview

  • Product Development Rationale
  • Overview of Biopharmaceutics
  • Overview of Clinical Pharmacology
  • Overview of Efficacy
  • Overview of Safety
  • Benefits and Risks Conclusions

Section C: Clinical summary

  • Summary of biopharmaceutic studies and associated analytical methods
  • Summary of clinical pharmacology studies
  • Summary of clinical efficacy
  • Summary of clinical safety
  • Synopsis of individual studies

Section D: Tabular listing of all clinical studies

Section E: Clinical study reports

OVERVIEW OF ICH – CTD AND ACTD
In the present section an attempt has been made to compare the drug regulatory approval procedure and requirements for the registration of pharmaceuticals for human use ICH countries and ASEAN. The main points of divergence are in the content and format of the registration dossier.

The ACTD consists of Parts I to IV which have subsections A to F whereas ICH – CTD has 5 Modules with subsections that are numbered. The administrative data of Part I is part of ACTD whereas Module 1 of ICH – CTD is purely country specific. The summaries of the quality (Part II), nonclinical (Part III) and clinical (Part IV) are located at the beginning of each part of the ACTD. The ICH – CTD dedicates these summaries in a separate Module 2. As the ACTD does not have such summary part, it consists of only 4 Parts and not 5. The main differences between the ICH - CTD and ACTDare listed below in Table II.

Table II:  Overview of ICH – CTD and ACTD

DOCUMENTS

ICH - CTD

ACTD

Administrative Documents and Product Information

Module 1

Part I

CTD Overview and Summaries

Module 2

Incorporated in parts II, III & IV

Quality Documents

Module 3

Part II

Non – clinical Documents

Module 4

Part III

Clinical Documents

Module 5

Part IV

CONCLUSION
Every country has its own Drug Regulatory Authorities, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of a drug. Therefore, it is very difficult, especially for the companies with global approach to develop one single regulatory approach for a Marketing Authorization Application (MAA) for a new drug on the basis of one dossier submitted simultaneously to different countries in the world. It is very important to know in detail and exactly the regulatory requirements in each concerned country where a Registration Dossier should be submitted to establish a suitable regulatory strategy before the submission in order to avoid any major difficulties.

Regulatory standards in ICH countries (EU, USA and Japan) have been progressively tightened. They have developed a common for submission for MAA. All drug application submissions must be made in the CTD format. Non – ICH countries include all the countries outside the ICH. Non – ICH countries represent countries with low income and less developed regulations. They do not have sufficient technical and regulatory resources to comply with the ICH guidelines.

Therefore, due the variations in the regulatory norms in the Registration Dossier in different countries of the world, there is a strong need for harmonization either by the ICH or WHO as the Regulatory Agency for harmonized approval of drugs at the global level.

REFERENCES
1. archives.who.int/tbs/qual/s2300e.pdf (Accessed on August 22nd , 2011)
2. dictionary.reference.com/browse/dossierupport  (Accessed on August 22nd , 2011)
3. apps.who.int/prequal/info_general/documents/WHO_DMP_RGS_98_5_R.pdf (Accessed on September 7th, 2011)
4. en.wikipedia.org/wiki/Marketing_authorization (Accessed on September 7th, 2011)
5. policycures.org/downloads/DNDi_Registering_New_DrugsThe_African_Context20100108.pdf (Accessed on September 20th, 2011)
6.    ich.org/products/ctd.html (Accessed on September 30th, 2011)
7. en.wikipedia.org/wiki/Association_of_Southeast_Asian_Nations (Accessed on October  9th, 2011)
8. moh.gov.bn/pharmacyservices/download/ASEAN%20Common%20Technical%20Document%20(ACTD).pdf
9.    ich.org/about/history.html (Accessed on July 1st, 2011)
10. ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organization/M4_R3__organization.pdf (Accessed on July 23rd, 2011)
11. ich.org/products/ctd.html  (Accessed on July 25th, 2011)
12. aseansec.org/about_ASEAN.html  (Accessed on September 10th, 2011)
13. wikipedia.org/wiki/Association_of_Southeast_Asian_Nations (Accessed on September 10th, 2011)
14. bpfk.gov.my/berita%20-%20berita/April%202001%20asean.htm (Accessed on November 6th, 2011)
15. pacificbridgemedical.com/services/regulatory/registration/others-drugs (Accessed on November 19th, 2011)
16. moh.gov.bn/pharmacyservices/download/ASEAN%20Common%20Technical%20Document%20(ACTD).pdf (Accessed on September 13th, 2011)

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