Ministry of Health, Brunei
Drug Administration Section (DAS)/. Brunei Darussalam Medicine Control authority (BDMCA)
https://www.moh.gov.bn/SitePages/Drug%20Administration%20Section.aspx
Yes
5 years.
One of the primary duties is carrying out the drug registration system to guarantee that pharmaceuticals that are imported, produced, supplied, and sold in Brunei Darussalam are safe, effective, and of a satisfactory caliber. Provisional drug registration (PDR), however, has been in place since April 2006, pending the introduction of a full drug registration system with appropriate legislative backing. Phased adoption of PDR is done in accordance with the various medication classifications.
2. The Provisional Drug Registration Committee (PDRC)
Founded in August 2007 and meets once a month to address PDR applications that have been filed and thoroughly reviewed, including variant applications. The difficulties brought up by the adoption of provisional drug registration were also considered by the PDRC.
In compliance with the ASEAN Cosmetic Directive (ACD) and the Medicines (Cosmetic Products) Regulations, 2007, the Cosmetic Unit manages the cosmetic notification process. Before releasing the product onto the local market, the responsible individual or firm must declare in advance that they are in conformity with the notification procedure. The accountable party must guarantee that the cosmetic product meets the safety and quality standards. On June 3, 2008, the notification process for cosmetic items went into effect. The Chief Scientific Officer leads this division.
The Department of Pharmaceutical Services (DPS) under the Ministry of Health oversees the registration process for all medicinal products intended for human use in Brunei Darussalam.
The regulatory framework for medicinal products in the country includes the Medicines Order 2007, Medicines (Licensing, Standard Provision and Fees) Regulations 2010, Medicines (Labelling) Regulations 2010, and the Poisons Act 1956. It is a requirement for local manufacturers, wholesalers, and importers of medicinal products to obtain the necessary licenses before commencing their business operations.
The primary goal of medicinal product registration is to guarantee the safety, efficacy, and high quality of medicinal products available in Brunei Darussalam’s market. The Brunei Darussalam Medicines Control Authority (BDMCA), established under Section 5 of the Medicines Order 2007, possesses the authority to issue, renew, modify, suspend, and withdraw licenses and certificates as stipulated in this Order.
The BDMCA will approve a product license for a pharmaceutical that has been given approval to be registered in Brunei Darussalam. Pharmaceuticals that are registered with any of the standard regulatory organizations in nations like Singapore, Malaysia, Australia, Canada, the EU (centralized).
The registration procedure for pharmaceutical products will be facilitated by the United States of America and the United Kingdom.
A new medicinal product registration application is divided into 3 types-
Applies to the new medicinal product containing:
Note: (*Never registered in Brunei Darussalam previously)
applies to any medication that has a striking resemblance to one that is now under registration in Brunei Darussalam. Biological or biotechnological products cannot be called generic.
Applies to any medication registered in at least one benchmark nation and designated as GSL (for specific * categories only).
(*antiseptics/skin disinfectants; lozenges/pastilles; health supplements; topical analgesics/counterirritants; emollients/demulcents; keratolytic; topical nasal decongestants. This list is non-exhaustive.)
All applications for the registration of medicinal products must be submitted with the necessary paperwork in accordance with the ASEAN Common Technical Requirements (ACTR) and the ASEAN Common Technical Dossier (ACTD) for the registration of pharmaceuticals for human use. The necessary application dossier will be divided into the following four sections:
The following factors will determine the data requirements:
Application Type | Data requirements |
1) Innovator product | |
· Innovator product registered for less than 5 years in at least one benchmark country | Parts I, II, III and IV |
· Innovator product registered for less than 5 years in at least one benchmark country containing existing chemical/biological entity(s) in a new dosage form | Parts I, Part II and pharmacokinetic data |
· Innovator product registered more than 5 years in 3 benchmark countries | Parts I and II |
2) Generic product* | Parts I and II |
3) Abridged application | Part I only |
Note: *With the “Grandfather” Product included. According to BDMCA, pharmaceuticals that were on the market prior to 2004 are considered “grandfather” goods.
The documents required for Part I, Part II, Part III and Part IV are as follows:
Section 1: Application Form – Form No: BDMCA/DPS/01
Section 2: Letter of Authorisation
Section 3: Certifications Section
Section 4: Labelling Section
Section 5: Product Information
Section 1: Application Form for Quality Requirements of the Drug Substance (Form No. BCMCA/DPS/02/A)
Section 2: Application Form for Quality Requirements of the Drug Product (Form No. BCMCA/DPS/02/B)
Section 1: Table of Contents
Section 2: Non-clinical Overview
Section 3: Non-clinical Summary (Written and Tabulated)
Section 4: Non-clinical Study Reports (As requested)
Section 5: List of Key Literature References
In reference countries where the original goods have already been registered and authorized for marketing authorization, Non-clinical Study Reports (Section D) might not be necessary. Thus, individual Study Reports may be sought for appropriate papers if needed.
Generic products, certain Major variation products, and minor variation products are exempt from the requirement for non-clinical papers (Part III).
Note: Part I and Part II must be presented in hard copy to be considered. Parts III and IV may be submitted on a CD or DVD.
Section 1: Table of Contents
Section 2: Clinical Overview
Section 3: Clinical Summary
Section 4: Tabular Listing of All Clinical Studies
Section 5: Clinical Study Reports (If applicable)
Section 6: List of Key Literature References
Certain Major Variation Products, Generic Products, and Products with Minor Variations do not require a Clinical Summary (section C). If the original products have already been registered and given the go-ahead for market authorization in the reference countries, then the Clinical Study Reports for NCEs, Biotechnological Products, and other Major Variation Products may not be necessary for ASEAN member nations. Nonetheless, the Clinical Study Reports may be asked for more papers if necessary.
NCEs, biotechnological products, and other major variation products might not need Clinical Study Reports (Section E) if the original products have previously received market permission and registration in Reference Countries. Thus, if necessary, Requests for Study Reports for required documents may be made.
The $200 processing fee must be paid at the time the application for a medical product registration is submitted. Regardless of the BDMCA’s ultimate judgment, the processing fee is non-refundable after the application has been filed.
The product license certificate has a five-year validity period. The first year is free of charge, and after that, a $50 fee must be paid each year.
After the BDMCA approves the modification, the amendment charge is due. The major amendment charge is B$150, while the small amendment price is B$50.
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