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Brunei Drug Product Registration

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Brunei Drug Product Registration

Drug registration in Brunei

Ministry of Health

Ministry of Health, Brunei 

MoH website

http://moh.gov.bn/

Regulatory Authority

Drug Administration Section (DAS)/. Brunei Darussalam Medicine Control authority (BDMCA)

Link for Regulatory Authority

https://www.moh.gov.bn/SitePages/Drug%20Administration%20Section.aspx

Local Authorised Representative

Yes

Product Classification

  1. Prescription Only Medicine (POM)
  2. Pharmacy only medicine (P); or
  3. General Sale List medicine (GSL)

Registration Validity

5 years.

Schedules

  • Submission of application for drug registration:
    Monday and Wednesday (by appointment only)
  • Cosmetic product notification:
    Submission of cosmetic product notification form: Tuesday and Thursday (7.45 am – 12 noon)
    Payment: (working days – 7.45 am – 12 noon)

Overview

  • The Department of Pharmaceutical Services (DPS) within the Ministry of Health (MOH) oversees the registration process for all human-use pharmaceuticals in Brunei.
  • Under the Medicines Order of 2007, the Department of Pharmaceutical Services (DPS) in Brunei Darussalam is the branch of the Medicines Control Authority (BDMCA) that makes decisions about registration and the granting, renewing, varying, suspending, and revoking of licenses and certificates for medicinal products.
  • The Drug Administration Section (DAS) is one of the regulatory arms of the Department of Pharmaceutical Services.
  • DAS’s primary goals are to guarantee that medications used in Brunei Darussalam are safe, effective, and of a quality that is acceptable as well as that cosmetics sold there adhere to safety and quality standards. By achieving this goal, the department’s drug regulatory control in Brunei Darussalam would be strengthened even further.
  • There are two DAS units operating now. They are as follows:
  1. Unit of Registration
  2. Cosmetic Section
  • In addition to these, DAS will ultimately oversee the surveillance program, GMP, and licensing. After the necessary resources and legal and physical infrastructure are in place, these functions will be gradually deployed.

Functions and Activities

1. Drug Registration Unit (DRU)

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.

3. Cosmetic Unit

 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.

Introduction

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.

Application Procedure for Medicinal Product Registration

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.

Application Type

A new medicinal product registration application is divided into 3 types-

1. Innovator product (NCE / Biotech)

Applies to the new medicinal product containing:

  • a new* chemical/biological entity;
  • a new combination of existing chemical/biological entity(s);
  • existing chemical/biological entity(s) in a new dosage form;
  • existing chemical or biological entity(s) for use by a different route of administration.

Note: (*Never registered in Brunei Darussalam previously)

2. Generic Product

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.

3. Application for Registration of Medicinal Products via the Abridged Route

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.)

Registration Dossier

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:

  1. Part I: Administrative Data and Product Information.
  2. Part II: Quality.
  3. Part III:  Non-Clinical or Safety
  4. Part IV:  Clinical or Efficacy

  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:

Part I: Administrative Data and Product Information

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

Part II: Quality

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)

Part III: Non-Clinical

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.

Part IV: Clinical Documents

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.

Application Fees

The Processing Charge

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.

Product Licensing Charge

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.

Amendment Charge

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.

Procedure of Application for Registration of Medicinal Product

Stage 1: Receipt of application by appointment (1 day)

  • Obtain application forms from DRU or MOH website
  • Fill application forms according to guideline
  • Make appointment with DRU for submission of application
  • Submit application forms with relevant documents to DRU
  • Screening of product application dossier by DRU for completeness according to checklist Payment of processing fee of B$200 per product I
  • Issuance of receipt of payment and Acknowledgement slip with Screening Ref. No. by DRU

Stage 2: Acknowledge receipt of application (10 day)

  • Validation for completeness of the product application dossier by DRU
  • Issuance of Acknowledgement letter of receipt of application with LOA Ref. No. by DRU

Stage 3: Evaluation (NCE: 225 days Generic: 110 days Abridged: 110 days)

  • Evaluation by DRU

Stage 4: Reporting (90 days)

  • Report of evaluation and recommendations to DRC
  • Report of recommendations from DRC to BDMCA for final decision

Stage 5: Certification (10 days)

  • Applicant is informed
  • Payment of Product License fee of B$200 (valid for 5 years)
  • Issuance of receipt of payment by DRU
  • Incomplete Issuance of Product License Certificate by DRU