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Sharan Murugan
May 8, 20221 min read
Pakistan's Guidelines on Therapeutic Good Import & Export Permissions
Pakistan's Drug Regulatory Authority (DRAP) has finalized its guidelines for imports and exports of therapeutic goods. This document...
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Sharan Murugan
May 2, 20221 min read
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...
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Sharan Murugan
May 2, 20221 min read
USFDA Guidance on Electronic PostMarketing Safety Reporting
US Food and Drug Administration (FDA) finalized guidance for submitting postmarketing safety reports for drugs and biologics...
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Sharan Murugan
May 2, 20221 min read
Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA
Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to...
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Sharan Murugan
May 2, 20221 min read
Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA
The Philippines' Food and Drug Administration (FDA) is seeking feedback on draft guideline aimed at streamlining the process of changing...
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Sharan Murugan
Apr 24, 20221 min read
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...
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Sharan Murugan
Apr 24, 20221 min read
SFDA's Product Classification Guidance
On 20 April, 2022 the Saudi Food and Drug Authority’s (SFDA’s) updated its Product Classification Guidance. This guidance presents the...
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Sharan Murugan
Apr 24, 20221 min read
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...
114 views0 comments
Sharan Murugan
Apr 24, 20221 min read
Malaysia’s MDA- Draft Medical Device Labeling Guidance
The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...
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Sharan Murugan
Apr 17, 20221 min read
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...
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Sharan Murugan
Apr 17, 20222 min read
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
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Sharan Murugan
Apr 17, 20221 min read
Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...
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Sharan Murugan
Apr 17, 20221 min read
FDA's MAPP on Complex Product Classification for Generic Development
On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...
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Sharan Murugan
Apr 17, 20221 min read
HPRA Guide to Parallel Imports of Human Medicines - Ireland
The Health Products Regulatory Authority (HPRA) updated its guidance on "Parallel Imports of Human Medicine" last week. Parallel...
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Sharan Murugan
Apr 10, 20221 min read
FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...
13 views0 comments
Sharan Murugan
Apr 10, 20222 min read
EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)
On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...
175 views0 comments
Sharan Murugan
Apr 10, 20222 min read
ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study
As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...
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Sharan Murugan
Apr 6, 20221 min read
Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA
On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...
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