Showing posts with label Medicinal Product Registration. Show all posts
Showing posts with label Medicinal Product Registration. Show all posts

Thursday 24 October 2013

Why Antibody Lots Differ Significantly


Featured Story
Since antibodies first attained prominence as research reagents in modern biological science labs, researchers have been perplexed as to why one production lot can differ significantly from the next, in terms of performance. Poor antibody performance has caused the loss of countless hours of research, to say nothing of the mental anguish of the researchers themselves. An antigen is a substance that stimulates the production of antibodies.
 http://www.dddmag.com/news/2013/10/why-antibody-lots-differ-significantly?et_cid=3555713&et_rid=523035093&type=cta
fig is Schematic representation of pure and contaminated antibodies carrying histones or histones complexed with DNA. (Source: Biochemistry and Cell Biology)

Tuesday 10 September 2013

Guidance on Medicinal Product Registration in Singapore

Singapore Government

Singapore Drug Registration Information and Guidelines

Guidance on Medicinal Product Registration in Singapore

Guidance on Medicinal Product Registration in Singapore (Effective 1 April 2011)
Appendices
1.      Target Processing Timelines
2A.    Application Checklist for NDA & GDA (ICH CTD) (Feb 2012)
2B.    Application Checklist for MAV (ICH CTD)
3A.    Application Checklist for NDA & GDA (ACTD) (Feb 2012)
3B.    Application Checklist for MAV (ACTD)
4.      Flowchart on Translation of Non-English Documents
5.      Guideline on Submission for Non-Prescription Medicinal Products
6.      Points to Consider for Singapore Labelling
7.      Patent Declaration Form
8.      Singapore Quality Overall Summary for Chemical Drugs
9.      Singapore Quality Overall Summary for Biologics
10.    Guideline on the Registration of Human Plasma-derived Medicinal Products
11.    Guideline on the Registration of Human Medicinal Products Containing Materials of Animal Origin
12.    Product Interchangeability and Biowaiver Request for Chemical Generic Drug Applications
12A. Quick Reference for Acceptability of Bioequivalence Study
13.    Guideline on Submission under CECA Scheme
14.    MIV Filing and Submission Inquiry Form
15.    Guideline on MIV Applications for Chemical Drugs
16.    Guideline on MIV Applications for Biologics
17.    Guidance on Registration of Similar Biological Products in Singapore
Template Downloads (MS Word format)
Appendices
 
2A.     Application Checklist for NDA & GDA (ICH CTD) (Feb 2012)2B.     Application Checklist for MAV (ICH CTD)
3A.     Application Checklist for NDA & GDA (ACTD) (Feb 2012)3B.     Application Checklist for MAV (ACTD)
7.       Patent Declaration Form
8.       Singapore Quality Overall Summary for Chemical Drugs
9.       Singapore Quality Overall Summary for Biologics
10.     Checklist for Registration of Human Plasma-derived Medicinal Products
11.     Checklist for Registration of Human Medicinal Products Containing Materials of Animal Origin
12A.  Quick Reference for Acceptability of Bioequivalence Study
14.     MIV Filing and Submission Inquiry Form
15.     Part B Checklist for MIV-1 Applicaitons for Chemical Drugs 
           
Part C Checklist for MIV-2 Applications for Chemical Drugs
16.     Part B Checklist for MIV-1 Applications for Biologics
           Part C Checklist for MIV-2 Applications for Biologics
           Part D Checklist for Plasma MAster File Variations for Biologics

Guidance on Registration of Similar Biological Products in Singapore


Other Application / Submission Guidelines


ASEAN Registration of Pharmaceuticals for Human Use


ASEAN Common Technical Requirements (ACTR)

Industry consultations

Please click here for a list of public consultations