Bioequivalence

Details of the following as entered under Product Validation will appear automatically in the application form:

1. Product name; 
2. Name and Strength of Active Ingredients, Name and Strength of Excipients; and
3. Dosage form.

• State briefly on visual and physical characteristics of the product.
• For injections packed with diluent, description of the product must include description of the diluent
• Description must include the appearance after the product is diluted/mixed with water or other proposed diluents(s) (for suspension, powder for injection etc)
• Explain the markings for tablet, the meaning of the logo, can the tablet be cut into half or not (scoring should suit its dosing)
• If the scored tablet is not meant to be cut, this should be stated in A4.
• If capsule, to describe capsule contents
• Different strengths of tablets should have different sizes. Should state size (mm unit, etc) for each strength of tablet and the size should not be the same.

Please provide a concise and comprehensive summary of the pharmacological profile i.e. main and supplementary pharmacological effects (mechanism of action, actions other than the therapeutic effects).
Please state the pharmacodynamics of each active substance accordingly. Information must be supported with reliable references.

Please provide a concise and comprehensive summary of the pharmacological profile i.e. relevant pharmacokinetics (absorption, plasma-protein binding, distribution, biotransformation, metabolism, excretion, etc)
Please state the pharmacokinetics of each active substance accordingly. Information must be supported with reliable references.

• Indication for generic product should be standardized with reference product registered in Malaysia
• State briefly on the recommended clinical use(s) of product, indicating clearly whether curative, palliative, adjunctive, diagnostic, etc.

• Recommended dose for generic product should be standardized with reference product registered in Malaysia
• Please state the dose (normal dose, dose range) and dosage schedule (frequency, duration); and route of administration appropriate for each therapeutic indication.
• Dosage for adults, and, children (where appropriate) shall be stated.
• Dosage adjustments for special conditions, e.g. elderly, renal, hepatic, cardiac, nutritional insufficiencies (where relevant) shall be stated.
• Where appropriate, diluents and instructions for dilution, reconstitution and use or administration of the product shall be clearly stated.
• Distinction shall be made between therapeutic and prophylactic doses, and between dosages for different clinical uses, where applicable.
• Ensure that dosage recommendation is relevant and appropriate for the product

Please select route of administration from the drop-down list.

• Please state conditions for which or under which the product shall not be used.
• Indicate clearly which conditions are :
  • absolutely contraindicated;
  • contraindicated but may be used under special circumstances and what precautions to be taken in such cases.
• Where there is likelihood that additives are added, especially for intravenous solutions, foreseeable contraindicated additives shall be mentioned (where applicable).
• Concurrent drug therapy which are contraindicated shall also be included where possible (where applicable). 

• Please state briefly on warnings and precautions, where necessary to ensure safe use; and efficacious (where applicable) of the product.
• Information must be supported with reliable references.

Please refer:

1. Appendix 7 : Special Conditions For Registration For A Particular Product Or Group Of Products 
2. Appendix 9: Labelling Requirements

Please state interactions which are observed and/or for which there is potential clinical significance.
Interactions may occur with:

• medicinal products used for the same indication;
• medicinal products used for other indications;
• meals, or specific types of food.

Information must be supported with reliable references.

Use in Pregnancy:
The following should be mentioned to ensure the safe use of the product and the recommendations regarding the use of the product in pregnant women/lactating mother.

1. conclusions from the animal reproduction/fertility study and the human experience
2. the risk in humans at different times of pregnancy, as assessed from (a)
3. information on the possibility of using the medical product in fertile and pregnant women

Use in Lactation:

• When the active substance(s) or its metabolites are excreted in milk, recommendations as to whether to stop or continue breast feeding, and the likelihood and degree of adverse reaction in infant shall be stated.
• Information must be supported with reliable references.

• Please state information on the severity and frequency, the side effects, adverse reactions, toxic effects, etc. (i.e. reactions, toxic effects, other than those desired therapeutically) including reactions such as allergy, hypersensitivity, drug dependence, addiction, carcinogenicity, tolerance, liver/ kidney toxicity etc
• Indicate also symptoms and sites of effects/ reactions.
• Reactions, whether minor or serious shall be stated.
• Severity, reversible, frequency of occurrence shall be indicated, wherever possible.
• Clinical tests for detection of “sensitive” patients, measure for management of adverse reactions developed shall be described wherever possible.
• Information must be supported with reliable references

• Please state briefly symptoms of overdose/ poisoning, and where possible, recommended treatment and antidotes for overdose/ poisoning.
• Information must be supported with reliable references.

Please state briefly precautions and warnings necessary to ensure safe and efficacious use of the drug, e.g. caution against driving motor vehicles or manning heavy machinery after intake of produ

Not applicable to generic product.

Please state the instructions for use.

• Please state the recommended storage conditions (temperature, humidity, light etc.). The statement on storage condition must be in line with label and PI.To follow Zone IVB recommendation i.e. Store below 30oC. Protect from light and moisture.
• Information includes storage condition before first opening, after reconstitution/ dilution and/or after opening , where applicable. Stability data to support such storage condition shall be submitted.

Reference ASEAN Guidelines:

1. ASEAN Guideline on Stability Study of Drug Product
2. ASEAN Guideline on Stability Study of Drug Product (Q&A)

Reference ICH Guidelines:

1. Stability Testing of New Drug Substances and Products (Q1A)
2. Stability Testing: Photostability Testing of New Drug Substances and Products (Q1B)

Reference EMA Guidelines:

1. Declaration of storage conditions for medicinal products particulars and active substances
2. In-Use stability testing of human medicinal products
3. Maximum shelf-life for sterile products for human use after first opening or following reconstitution

• Shelf life for all the listed packaging material shall be supported by stability data.
• Information includes shelf life before first opening, after reconstitution/dilution and/or after opening where applicable shall also be provided. Stability data to support such shelf life shall be submitted.
• Evidence is required to demonstrate that the product is stable which meets the finished product shelf life specifications throughout its proposed shelf-life.

1. Please indicate WHO assigned ATC code for each distinct therapeutic indication proposed for a product, if such a code is available. 

   Please refer:

   ATC/ DDD index

Not applicable to generic product.