What Is a Regulatory Dossier? A Complete Guide
In the pharmaceutical, cosmetics, and medical device sectors, a regulatory dossier plays a very significant role in securing registration and product approval from domestic and international regulatory authorities. A regulatory dossier provides a well-structured representation of product data and compilation of all documents together showcasing the quality, safety, and efficacy of the product. Let’s know deeply about what is a regulatory dossier and what it contains. This guide overviews the various types of dossiers along with the technical learning.
What Is A Regulatory Dossier?
A regulatory dossier is a collection of documents, including all the related information regarding a new drug product or generic drug product, required by country-specific regulatory authorities like Europe (EMA), United States of America (USFDA), and India (CDSCO) for grant of marketing authorization for the product. It serves as a blueprint of the product lifecycle, manufacturing process, quality, safety, and efficacy data of the product. Regulatory authorities analyze the dossier to ensure the product is in compliance with the regulatory standards before obtaining marketing authorization.
Why Is Regulatory Dossier Important?
Regulatory dossier is important for the following purposes:
- Product Compliance: To ensure global regulatory compliance of product.
- Marketing Authorization: For obtaining market access of product for commercialization in approved region or country.
- Product Lifecycle Management: It facilitates product variation, renewal, and post-approval changes of product.
- Globally Import/Export: Aligning with country-specific regulatory guidelines and requirements, allow products to enter into new markets, resulting in international import and export of products.
Types of Regulatory Dossier In Regulatory Affairs
It can be classified based on the product, region, and country of regulatory submission:
Common Technical Document (CTD)
CTD is a well-structured format accepted by various regulatory authorities, including USFDA, EMA, and PMDA. CTD dossier consists of five modules as discussed below:
- Module 1: Administrative information and regional information.
- Module 2: Summary of Module 3, 4, & 5.
- Module 3: Quality data of drug product.
- Module 4: (Non-clinical) Safety data of drug product, which is not applicable for generic drugs.
- Module 5: (Clinical) Efficacy data of drug product.
Read Also: Complete Guide To CTD Dossier
Electronic Common Technical Document (eCTD)
eCTD dossier is an electronic version of CTD dossier for digital regulatory submission. It enhances accessibility, traceability, and product lifecycle management for submission to regulatory authority. eCTD dossier has been mandatory for obtaining registration of product by USFDA, EMA, and WHO.
Also read: eCTD Submission Latest Validation Criteria
ACTD
ASEAN Common Technical Document (ACTD) dossier is prepared for ASEAN countries like Myanmar, Singapore, Philippines, Indonesia, and Thailand. ACTD dossier includes four parts:
- PART I: Administrative and regional information.
- PART II: Quality data of drug substance and drug product with body of data and Quality Overall Summary for both drug substance and drug product.
- PART III: Non-clinical data of drug product which is excluded for abbreviated drug product also known as generic drugs.
- PART IV: Includes clinical data of drug product.
New Drug Application (NDA)
An NDA is submitted to regulatory authority like USFDA for approval of New Pharmaceutical Products. Data included in NDA includes: Drug safety and efficacy data, Manufacturing process data, Labeling and packaging data.
Abbreviated New Drug Application (ANDA)
ANDA is an application submitted to regulatory authority for the purpose of registration for generic drugs. It is necessary for ANDA to demonstrate generic drug is bioequivalent to innovative drug product.
Biologics License Application (BLA)
BLA is submitted to regulatory authority for the approval of biological products such as sera, vaccine, blood products, and gene therapies.
Drug Master File (DMF)
DMF contains confidential information of manufacturing site, facilities, drug substance, Intermediate substance, excipients, and packaging data of drug product. There are five types of DMF:
- Type I: Having information about manufacturing site and facilities. (Note: Discontinued by FDA in 2000; information now included directly in applications.)
- Type II: Detail information about drug substance and intermediates.
- Type III: Packaging material information is included in this DMF.
- Type IV: Information provided in this DMF includes excipients, coloring agent, and flavors.
- Type V: This DMF includes FDA accepted reference information.
Best Tips For Fast Regulatory Dossier Submissions
Here are some best tips for quick regulatory dossiers submission:
- Thorough Documentation: You must assure accuracy in complete documents and ensure all documents must meet regulatory compliance.
- Regulatory Expertise: You must know the regulatory requirements of local and International regulatory authorities, to avoid compliance errors.
- Latest Updates: Be updated with latest regulations and news regarding regulatory submissions, address encountered challenges of variation, renewal, and post approval changes.
- High Quality Documents: Perform validation check on documents to achieve quality, neglecting mistakes, and resulting in fast regulatory dossier submissions.
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FAQs
Certificate of Suitability (CEP) certifies the Active Pharmaceutical Ingredients (API) and excipients as per the monographs of European Pharmacopoeia. It simplifies the registration process by confirming API quality without needing the full technical dossier in relevant sections.
ASMF is the Active Substance Master File that is submitted to regulatory authority for product approval along with the whole regulatory dossier. It protects the confidential intellectual property of the active substance manufacturer (formerly known as European Drug Master File or EDMF).
The cost of regulatory dossier preparation varies on products like (Pharmaceuticals, Medical Device, or Cosmetics dossier), depending on the difficulty and regional specific regulatory framework.
- Basic dossier preparation cost is $5000 to $10000
- For global dossier cost may vary because of specific regulatory requirements
One must follow International Council For Harmonization (ICH) guidelines for preparation of CTD and eCTD dossier template. Follow specific regulatory requirements like USFDA guidelines for USA, and EMA guidelines for Europe to avoid non-compliance.
