REGISTRATION DOSSIER OF PHARMACEUTICALS
Maharshi Dayanand University,
The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for human use”. Process of reviewing and assessing the dossier of a pharmaceutical product containing its detailed data (administrative, chemistry, pre-clinical and clinical) and the permission granted by the Regulatory Agencies of a country with a view to support its marketing / approval in a country is called as the “Marketing Approval or the “Registration” “Marketing Authorization” or the “Product Licensing”.
“Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country. It is more commonly called as the New Drug Application (NDA) in the USA or Marketing Authorization Application (MAA) in the European Union (EU) and other countries, or simply Registration Dossier. Basically, this consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyzes of finished product. Therefore, they are the vehicle in a country through which drug sponsors formally propose that the Regulatory Agencies approve a new pharmaceutical for sale and marketing.
REFERENCE ID: PHARMATUTOR-ART-1485
The goals of the dossiers are to provide enough information to permit Regulatory Agencies’ reviewers to establish the following:
• Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks?
• Is the drug’s proposed labelling (package insert) appropriate, and what it contain?
• Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?
Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy.
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, filing of Registration Dossier/ New Drug Application (NDA) and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. The single regulatory approach for marketing authorization of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for Registration Dossier of each country should be known to establish a suitable regulatory strategy.
Drug registration implements one of the legal requirements for marketing of drugs in a country. Drug registration guidelines provide guidance to applicants who may wish to market their pharmaceutical products in the market. They intend to assist applicants in the preparation of acceptable application documents. It is therefore essential that every person who intends to market a medicinal product in country reads the whole of these guidelines carefully and follows strictly the instructions prescribed herein. Submission of applications, which do not comply with the prescribed requirements, may result in delays, queries or rejection of registration.
The content and format of the dossier must follow rules as defined by the Competent Authorities.
REGULATORY DOSSIER SUBMISSION IN ICH COUNTRIES
The complete name of ICH is the "International Conference on harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use". ICH is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines. The goal of ICH is to promote international harmonization by bringing together representatives from the three ICH regions (EU, Japan and USA) to discuss and establish common guidelines.
For example, since year 2003, the authorities in the United States, the European Union (EU) and Japan ask for the Common Technical Document (CTD) format set out by the 2003 International Conference on Harmonization (ICH) which was agreed by the Regulatory Agencies of Europe, Japan and the US and the Research-based Industryand more recently, its electronic version - the electronic Common Technical Document(eCTD). CTD provides a common format for the submission of information to the Regulatory Agencies for the registration of the pharmaceutical product.
The CTD is organized into five modules as shown in Figure I. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. The agreement to assemble all the Quality, Safety and Efficacy information in the CTD format has revolutionized the regulatory review processes, led to harmonized electronic submission that, in turn, enabled implementation of good review practices.
Figure I: CTD Triangle
Module 1: Administrative Information and Prescribing Information
1.1 Table of Contents of the Submission Including Module 1.
1.2 Documents Specific to Each Region e.g. the application forms, labeling etc
Module 2: CTD Summaries
This module should begin with a general introduction to the pharmaceutical, including its pharmacologic class, mode of action, and proposed clinical use, not exceeding one page.
Module 2 should contain 7 sections in the following order:
· CTD table of contents
· CTD introduction
· Quality overall summary
· Nonclinical overview
· Clinical overview
· Nonclinical written and tabulated summaries
· Clinical summary
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