REGISTRATION DOSSIER OF PHARMACEUTICALS

 

Module 3: Quality
Information on Quality should be presented in the structured format as described below:
3.1      Table of Contents of Module 3

3.2          Body of Data

3.2. S              Drug substance(s)
3.2. S.1            General Information
3.2. S.2           Manufacture of Drug Substance (name, manufacturer)
3.2. S.3            Characterization of Drug Substance (name, manufacturer)
3.2. S.4            Quality Control of Drug Substance (name, manufacturer)
3.2. S.5            Reference Standards or Materials (name, manufacturer)
3.2. S.6            Container Closure System (name, manufacturer)
3.2. S.7            Stability of Drug Substance (name, manufacturer)

3.2. P               Drug product (name, dosage form)
3.2. P.1            Description and Composition of the Drug Product (name, dosage form)
3.2. P.2           Pharmaceutical Development (name, dosage form)
3.2. P.3          Manufacture of drug product (name, dosage form)
3.2. P.4          Controls of Excipients (name, dosage form)
3.2. P.5          Control of Drug Product (name, dosage form)
3.2. P.6          Reference Standards or Materials (name, dosage form)
3.2. P.7          Container Closure System (name, dosage form)
3.2. P.8          Stability (name, dosage form)

3.2. A                Appendices
3.2. A.1            Facilities and Equipment (name, manufacturer)
3.2. A.2            Adventitious Agents for Safety Evaluation (name, dosage form, manufacturer)
3.2. A.3            Excipients

3.3       Literature References

Module 4 : Nonclinical Study Reports
The nonclinical study reports should be presented in the order described below:
4.1       Table of contents of module 4

4.2       Study reports
4.2.1                Pharmacology
4.2.2               Pharmacokinetics
4.2.3               Toxicology

4.3       Literature references

Module 5 : Clinical Study Reports
The human study reports and related information should be presented in the order described below:
5.1       Table of contents of module 5
5.2       Tabular listing of all clinical studies
5.3       Clinical study report
5.4       Literature References

REGULATORY DOSSIER SUBMISSION IN ASEAN
Association of South –East Asian Nations (ASEAN) follows ASEAN – CTD. ASEAN is a geo-political and economic organization of ten countries located in Southeast Asia as shown in Figure II, which was formed on August 8, 1967 by Indonesia, Malaysia, Singapore and Thailand. Since then the membership has extended to Brunei, Myanmar, Philippines, Cambodia, Laos PDR and Vietnam. Even though some of the individual ASEAN countries have their own drug registration formats, all ASEAN countries accept the ACTD.

Figure II: ASEAN Member States

ASEAN Common Technical Dossier (ACTD) provides a common format for the preparation of well-structured Common Technical Dossier applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. CTD format significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. Regulatory reviews and communication with the applicant is facilitated by a standard document of common elements.

The ASEAN Common Technical Document is organized into four parts. The ACTD consists of Parts I to IV whereas ICH – CTD has 5 Modules. 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 ASEAN Common Technical Document is organized into four parts.

Part I.  Table of Contents, Administrative Data and Product Information
Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific documentation in details is put together such as application forms, label, and package insert etc. The last section of this part is Product Information where necessary information includes prescribed information, mode of action, side effects etc.
A.        Introduction

B.        Table of Contents

C.        Administrative Data and Product Information
1.         Application Form
2.         Letter of Authorization
3.         Certifications
4.         Labelling
5.         Product Information

Part II. Quality Document
Part II should provide the Overall Summary followed by the Study Reports. The quality control document should be described in details as much as possible.

Section A: Quality Overall Summary (QOS): Table I gives a view of the Quality Overall Summary of Part II of ACTD.

Table I: Quality Overall Summary of Part II of ACTD

S DRUG SUBSTANCE

P DRUG PRODUCT

S1   General Information

P1   Description and Composition

S2   Manufacture

P2   Pharmaceutical Development

S3   Characterization

P3   Manufacture

S4   Control of Drug Substance

P4   Control of excipients

S5   Reference Standards or Materials

P5  Control of Finished Product

S6   Container Closure

P6   Reference Standards or Materials

S7   Stability

P7   Container Closure

 

P8   Stability

 

P9   Product Interchangeability Equivalence          evidence

Section B: Table of Contents

Section C: Body of Data

Part III. Nonclinical Document
Part III should provide the Nonclinical Overview, followed by the Nonclinical Written Summaries and the Nonclinical Tabulated Summaries. 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.

NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.

SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org

Subscribe to PharmaTutor Alerts by Email

FIND OUT MORE ARTICLES AT OUR DATABASE


Pages

FIND MORE ARTICLES