Regulations

ICH works on Q7 guide for regulators

ICH working to clarify Q7 for regulators

By Gareth Macdonald

The ICH says regulator uncertainty over Q7 for ingredient supply chains, contractor management and quality management systems must be resolved.

What does Obama mean for Pharma this time?

What Obama means for Pharma this time

By Gareth Macdonald

Barack Obama’s re-election will mean millions more US citizens have health insurance, which has significant implications for the pharmaceutical industry.

USP revises Heparin labelling rules

USP revises heparin labelling guide

The US Pharmacopeial Convention (USP) has changed its labelling rules for heparin in a mid to reduce the number of medication errors.

Big Pharma campaign contributions favour Romney

Big Pharma contributions favour Romney

By Gareth Macdonald

Big Pharma firms want a Republican in the White House judging by contributions received by the two US parties during the current campaign.

PPMA calls for action Govt DRA

Pakistan drugmakers need Govt action on DRA says PPMA

By Gareth Macdonald

Drugmakers in Pakistan are suffering and parliament needs to implement on the proposed Drug Regulatory Authority (DRA) according to the Pakistan Pharmaceutical Manufacturers Association (PPMA).

Fercy receives FDA warning letter

Fercy receives FDA warning letter

Fercy Personal Care Products received an FDA warning letter after quality staff handed inspectors just two pages from a notebook as ingredient records.

Genetically modified corn could soon make drugs

GM corn could soon be used to make drugs

By Natalie Morrison

Genetically modified corn could soon be used to mass-produce the enzymes used in rare-disease therapies, according to new research.