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标题: 马来西亚注册分享 [打印本页]

作者: 冬瓜adl 时间: 2018-11-12 04:07 PM
标题: 马来西亚注册分享
最近在进行马来西亚注册，分享下官方NPRA网址：https://www.npra.gov.my/index.php/faq/product-registration
以及一些法规：（附件无法添加，如有需要可以在下面回复里写上自己邮箱）
Malaysia regruatory system for pharmaceutial product PPT；
Complete DRGD with appendices；
Scheduled Poison Screening Common Issues；
checklist for test method and validation；

以及一些自己总结的特殊注意点和疑惑。

SectionA

Name:
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Genericnames only are not allowed; Brand name requirement (No stand alone generic nameallowed)
Proprietaryname (invented name) or Generic name (common name) or scientific name togetherwith a trademark or the name of the manufacturer;
proposedproduct name cannot be similar to an existing registered product

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2.Dosage form: (wrong dosage form selected, application willbe rejected)

Mustbe exact! more concrete
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arenteral preparati**: lyophilized powder for injection or infusi**;Concentrates for infusi**

3.Storage condition

ClimacticZone IVB-long-term (30oC/75%RH) to support storage below 30oC,6m
-acc-term(40oC/75%RH), 6m
Studies:compatibility test; in-use study; position study (orientation-uprightand inverted)
Position study: glassampoules not needed, lyophilization powder request. (ExplanationNote guidance)-doit together with long-term stability.

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4.Concrete shelf life description

Beforefirst opening, after opening (瓶装;盒装),after rec**titution/dilution after opening（临用新配） (whereapplicable)

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SectionB

1.Product formula (request info inChecklist)

Batchmanufacturing formula should be in Companyletterhead and provide information request in Checklist in template form (annex 1). ( if the BMFis a range, c**ist with other secti**)
Overage (remifentanil HCl Inj: glycineis overage and API is not, but API needs to calculate the base equivalencestudy on salt form)

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SectionC

Justdescription

SectionD

6. Add 130. Opioids section of DRGD in PI and leaflet (RiMUP-no need for injection)
7. batch number, route ofadministration, package size (unit/ volume) is needed in immediate label. WhileMAC can be exempted for small labels (5ml or less) of ampoules and vails inimmediate label. But MAC and so on is mandatory in carton.
8. The use of terms such as “ambientconditi**” or “room temperature” is unacceptable.
9. RiMUP is compulsory for scheduledpois** (Category A)-not for injection of scheduledpois**
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SectionE

9. Company core data sheet (CCDS)?
10. E12，why is photocopies or methods directly copied from pharmacopeiaare not allowed? Only FP not allowed, but API and exp allowed?
11. E13, identification test needverification/validation.
RC and imp, bacterial endotoxin,sterility need validation.
12. E14, Any other supporting doc., suchas declaration.
13. E15, worldwide status including referencecountries (United Kingdom, Sweden, France, United States of America, Australia,Canada, Japan and Switzerland)

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**2

SectionA

P3.4,PV can use difference API manufacturers.
P4.2,protocol of exp analysis can be extracted from pharmacopoeia.
P5.1,two (2) specificati** includingboth release SPC & shelf life/ stability SPC.
P5.4,3 valid COA batches, batch size of COAshould be declared.
P7,CCS, photo of product is needed (medicine and medicinewith package). Details of primary and secondary pkg is needed (SPC, STP& COA)
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Stabilityin ASEAN

ZoneIV B condition:

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stresstesting( if API did acc stability, it is not needed): 40oC ± 2oC/75%RH ± 5% RH or at more stressful conditi**

(Stress testingis necessary for analytical method validation, pharmaceutical formulation,identifying and monitoring potential degradants during stability testing.)

Batchrequirement:

Packedin marketing CCS;
3batches for critical dosage form or unstable substance, at least 2 pilotbatches, 1 smaller.
Ifpossible, use 2 batches of API

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Specification:should have two SPC (release & shelf-life)
Testing:

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General testing: appearance, assay,degradation
Small volume parenterals: samples be stored in upright andinverted/on-the-side orientati**. Shouldbe evaluated for appearance, clarity, colour, assay, degradation products,particulate matter, pH, sterility and pyrogen/endotoxin
Freeze-dired products: should beevaluated for appearance of both thefreeze-dried and its rec**tituted product, assay, degradation products,pH, water content and rate of solution.

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Stabilitytest type:
Challenge test: in particularto sterility testing (microbiology test additional), should be carried out atleast at the beginning and at the end of the shelf-life, and the endotoxin testshould be conducted at the release testing
Photostability testing.
In-use sability, shouldbe performed on the rec**tituted or diluted drug product at the initial and finaltime points and intermediate time point if applicable on no less than 2 pilotbatches, At least one of these batches should be chosen towards the end of itsshelf life.
Position/ Orientation study: Forglass ampoule not required, Lyophilised powders/cakes still required as thereis still very slight chance of contact with closure
Accelerate stability expectation condition:Wherean expectation (based on development experience) exists that results fromaccelerated studies are likely to approach significant change criteria,increased testing should be conducted either by adding samples at the finaltime point or by including a fourth time point in the study design.
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