Common Technical Document Format Research Articles

Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council

Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.

An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia.

In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. The Tanzania Food and Drugs Authority is the drug regulatory body in Tanzania and it follows the Common Technical Document (CTD) format for dossier submission. However, Nepal is still a developing country with respect to the pharmaceutical sector. The drug governing body in Nepal, Department of Drug Administration, has its own nation-specific guidelines for drug regulation, but the CTD format is also acceptable for dossier submission. In Cambodia, the Department of Drugs and Food is the drug regulatory authority that comes under the Ministry of Health of Cambodia. As Cambodia is included in the Association of Southeast Asian Nations (ASEAN) body, it follows the ASEAN CTD (ACTD) format for dossier submission.

Determination of the investment project cost in developing a new generic medicine based on the content approach

Aim. To determine the approximate cost of an investment project in developing a new medicine based on the generic type in the form of tablets taking into account the content approach in the common technical document (CTD) format of the registration dossier. Materials and methods. As materials the reports on research work in developing drugs, scientific publications, the own research and monitoring results of the pharmaceutical market of pharmaceutical company “Farmstandart” were used. The methods of generalization, systematization of the theoretical and practical material, marketing analysis, comparative and economic methods were applied. Results. The analysis and generalization of materials in determining the cost of development of new drugs has been conducted. On the example of the generic type medicine in the form of tablets in accordance with the requirements of the normative documents to the formation of the registration dossier in the CTD format the cost of the drug development and the necessary investments for each of five modules has been processed. Conclusions. The importance and necessity of determining the cost of developing a new drug as a complex product project have been substantiated. On the example of the generic type medicine in the form of tablets taking into account the requirements of normative documents the definition of the cost of development by 5 modules of the registration dossier has been worked out.

An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia

In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. The Tanzania Food and Drugs Authority is the drug regulatory body in Tanzania and it follows the Common Technical Document (CTD) format for dossier submission. However, Nepal is still a developing country with respect to the pharmaceutical sector. The drug governing body in Nepal, Department of Drug Administration, has its own nation-specific guidelines for drug regulation, but the CTD format is also acceptable for dossier submission. In Cambodia, the Department of Drugs and Food is the drug regulatory authority that comes under the Ministry of Health of Cambodia. As Cambodia is included in the Association of Southeast Asian Nations (ASEAN) body, it follows the ASEAN CTD (ACTD) format for dossier submission.

Review on Study of format and content of Common Technical Document (CTD) and Electronic Common Technical Document ( eCTD) for preparation and submission of dossier to get marketing approval for US

The major pharmaceutical markets in the world like United States have requirements for the registration of a pharmaceutical product. To harmonize the requirements as per the regulatory agencies, a concept of common technical and its electric version was implemented by ICH. It is essential to submit dossier file in the form of common technical document in USA, Europe and Japan. CTD dossier divided in 5 modules such as administrative and prescribing information. In this competitive world of Pharma generics, an attempt is made to highlight registration requirements through CTD and eCTD format in this article. Key words : CTD, eCTD, ICH, ANDA

An overview of the Common Technical Document (CTD) regulatory dossier

The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided into five main modules: Module 1 – Administrative information and prescribing information; Module 2 – Overviews and summaries of Modules 3–5; Module 3 – Quality (pharmaceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (clinical trials). Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers.

International Marketing Applications according to the ICH CTD format: comparison of structure and document requirements

AbstractWith the development of the Common Technical Document (CTD) by the International Conference on Harmonisation (ICH), United States, European Union and Japan now have a common format for the organization of documents in regulatory applications. This paper presents a top‐level assessment of how the required technical contents of the Biologic License Application (BLA), the Marketing Authorization Application (MAA) and Japan's New Drug Application should be structured according to the ICH CTD format. The article may be of assistance for Quality Assurance auditor when auditing MAAs. Copyright © 2006 John Wiley & Sons, Ltd.