Section E New Chemical Entity

Product owner

Product owner is referring to person, company or entity who is the legal/registered owner of the product formulation and/or process with whom the marketing authorization holder has a contract.

E1.1 Role of Product Owner

Select one of the following for status of product owner:

• Manufacturer or
• Product registration holder or
• Product registration holder & manufacturer or
• Others (If the product owner is neither of the above status) - Key-in the name and address of the product owner by clicking on the ‘search’ button. If the product owner is not in the database, applicant need to click ‘Not Listed’ in order to enlist the new product owner

E1.2 Letter of Authorization from Product Owner

• All applications for registration shall be accompanied with Letter of Authorization from product owner.

• A letter from the manufacturer or product owner authorizing the local agent to be the registration holder and to be responsible for all matters pertaining to the registration of the product

(Not applicable if the Product Registration Holder is Product Owner).

• Letters of Authorization (LOA) shall be valid and current at the time of submission.
• The LOA shall be on the product owner‟s original letterhead and be dated and signed by the Managing Director, President, CEO or an equivalent person who has overall responsibility for the company or organization.
• The LOA shall state the name of the product concerned and also the name and actual plant address of the manufacturer(s) involved in the manufacture of the product.

E2.1 : Letter of Appointment of Contract Manufacturer from Product Owner (if related)

• Applicable for product which is contract manufactured by a manufacturer who is not the product owner.
• The letter shall be on the product owner’s original letterhead and be dated and signed by the Managing Director, President, CEO or an equivalent person who has overall responsibility for the company or organization.
• The letter shall state the name of the product concerned and also the name and actual plant address of the manufacturer(s) involved in the manufacture of the product.

E2.2 : Letter of Acceptance from Contract Manufacturer (if related)

• The letter of acceptance from the manufacturer shall be on the manufacturer’s original letterhead and be dated and signed by the Managing Director, President, CEO or an equivalent person who has overall responsibility for the company or organization.
• The letter of acceptance shall state the name of the product concerned and also the name and actual plant address of the manufacturer(s) involved in the manufacture of the product.

E2.3 : Letter of Appointment of the Repacker from the Product Owner

• Applicable when a product is repacked by another company (not by the manufacturer); where the owner is appointing the manufacturer to be the repacker of the product.

E2.4 : Letter of Acceptance from the Repacker

Applicable when a product is repacked by another company (not by the manufacturer); where the repacker is accepting the appointment by product manufacturer to be the repacker.

E3.1 Certificate of Pharmaceutical (CPP) – attachment & Certificate No.

• The certificate shall be valid and current at the time of submission 
  
  

E3.2 CPP Issuing Body

• Competent Authority who issued the CPP as stated on the CPP
• Check for the competent Drug Authority
• Select from list of database. If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

E3.3 Is this product licensed to be placed on the market for use in the exporting country? & Reason.

• Select YES or NO. If answer is ‘NO’, specify the reasons

E3.4 Is this product in the market in the exporting country and reason?

• Select YES or NO. If answer is ‘NO’, specify the reasons 

E3.5 Date of issue of CPP

• As stated on the CPP

E3.6 Date of expiry of CPP

• Applicable for Imported Product only
• CPP is mandatory for sterile preparations
• CPP shall be in the format of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

Certification Scheme (list available in WHO website)

• Must be issued by the competent authority in the country of origin.

• [CPP issued by EMA for products registered through the Centralized procedure in EU will be accepted].

• CPPs issued by the manufacturer or other authorities are not acceptable.
• In the event a CPP is not available from the country of manufacture e.g. where a product is not licensed for sale in said country because its manufacturer is manufacturing under contract only for product owner from anothercountry, the following alternatives may be considered:

GMP Certification/Manufacturing Licence for the manufacturer from the relevant competent authority, together with

• CPP from the country of the product owner; OR
• CPP from country of release, if (1) is not available
• Unless otherwise supported by justifications acceptable to the Authority, the following products are unlikely to be registered:

1. products not licensed/ certified for sale in the country of manufacture/ product owner;
2. products manufactured for export only (imported products).

E4.1 Certificate of Free Sales (CFS) & Certificate No.

• The certificate shall be valid and current at the time of submission

E4.2 CFS Issuing Body

• Please select from list of database the competent Authority who issued the CFS as  stated on the CFS .
• If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

E4.3 Date of issue of CFS

• As stated on the CFS

E4.4 Date of expiry of CFS

• Applicable for Imported Product only where the CPP is unavailable
• Must be issued by the competent authority in the country of origin. CFS issued by EMEA for products registered through the centralized procedure in EU will be accepted

E5.1 Certificate of Good Manufacturing Practice (GMP) & Certificate No.

• The certificate shall be valid and current at the time of submission

E5.2 GMP Issuing Body

• Please select from list of database the competent Authority who issued the cGMP as stated on the cGMP .
• If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

 E5.3 Date of issue of GMP

• As stated on the GMP certificate

 
E5.4 Date of expiry of GMP

• Applicable for Imported Product only.
• If more than one manufacturer is involved in the manufacture of a product, GMP certification should be available for all the manufacturers.
• Check for the competent Drug Authority issuing the cGMP, at this website: http://www.whocc.no/atcddd/
• Authority will usually recognize GMP Certification/ Manufacturing Licence issued by the relevant national or regional Veterinary Service or Department of Animal Health or Department of Agriculture

Reference :
Glossary Guidelines

• Manufacturer Name
• Manufacturer Address
• Processing Step
• GMP Certificate
• Please enter name of company and click button ‘search’ to select other manufacturer (e.g. repacker) listed in the database.
• For a new other manufacturer (repacker) which is not listed in the database search, please click ‘Not Listed Manufacturer’ button.
• Please select from processing type drop-down list, e.g. assembly, packing, production, labelling, fill and finish, others.

• Imported by the Applicant or others
• Please select imported name and address from list of database. If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

• Please select store name and address from list of database. If it is not listed, please click the ‘Not Listed’ button; upon which, the particulars should be provided by applicant.

• For Imported Product only
• Please attach (where applicable)
• Product information as approved by the drug regulatory authority(The SmPC serves as the source of information for health personnel as well as for consumer information on labels and leaflets of pharmaceutical products and for control of advertising
• Information must be in line with the Package Insert

Please attach (where applicable)

*Specification & Standard Testing Procedure (plant document)

The analytical procedures used for testing the drug product should be provided. Compendial requirements or appropriate information from the manufacturer.

Reference:

• Drug Registration Guidance Document (DRGD), Appendix 25 - Guideline for the Submission of Protocol of Analysis (POA)

Reference ICH Guidelines:

• Validation of Analytical Procedures: Text and Methodology (Q2)
• Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products -Chemical Substances (Q6A)

Validation of Analysis Protocol

*Analytical Method Validation (plant document)

Analytical validation information, including experimental data, for the analytical procedures used for testing the drug product, should be provided. Compendial requirements or appropriate information from the manufacturer.

• Assay:
• Specificity
• Precision (Intermediate)
• System Suitability Test

• Related Substance:

• Specificity
• Precision (Intermediate)
• System Suitability Test
• Limit of Quantitation/Detection

• Dissolution:

• BET:
• Routine Test / Limit Test/ Semi-quantitative test-3 Batches of Finished Products (Gel Clot), (Photometric Method)
• Method
• Result (raw data)
• Routine Test / CoA for Lysate and Endotoxin (Gel Clot), (Photometric Method)
• Method
• Result (raw data)
• Routine Test / List of Apparatus and Reagents (Gel Clot), (Photometric Method)
• Method
• Result (raw data)
• Validation Test / Confirmation of Labelled Lysate Sensitivity (Gel Clot) - 1 batch of endotoxin
• Method
• Result (raw data)
• Validation Test / Test for Interfering Factors (aka Inhibition/Enhancement Test) (Gel Clot) (photometric method) - 3 Batches of Finished Products
• Method
• Result (raw data)
• Validation Test / Standard Curve (Photometric Method)-1 Batch of Endotoxin
• Method
• Result (raw data)
  • Sterility
  • Routine Test / Sterility Test
  • Method
  • Result
  • Routine Test / Growth Promotion Test
  • Method
  • Result
  • Routine Test / Test for Media Sterility
  • Method
  • Result
  • Routine Test / Preparation of Media
  • Method
  • Result
  • Validation Test / Bacteriostasis & Fungistasis Test
  • Method
  • Result
  • Summary of method validation
  • Protocol Validation, Other Documents

•  

   

  Reference :

  • Drug Registration Guidance Document (DRGD), Appendix 26 : Guideline for the Submission of Analytical Method Validation (AMV) Documents

   

  Reference ASEAN Guidelines:

  • ASEAN Guideline for Validation of Analytical Procedures
  • ASEAN Guidelines for Validation of Analytical Procedures (Q&A)

   

  Reference ICH Guidelines:

  • Validation of Analytical Procedures: Text and Methodology (Q2)
  • Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products -Chemical Substances (Q6A)

Please attach (if any).

For Imported product ONLY

Please attach (if any).