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Canadian manufacturer hit with warning letter over cross-contamination issues

06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.

News in brief

Suspect Viagra pills seized in EU-wide swoop on organised crime gang

02-Jul-2015 - More evidence linking fake pharmaceuticals and organised crime emerged today with Dutch police seizing suspicious Viagra pills along with cocaine, MDMA and burglary tools.

UK will label drugs with their cost to the state

02-Jul-2015 - The UK health minister has announced plans to label all British prescription medicines with their cost to the taxpayer.

Staff cuts and accelerated access: MHRA’s plan for 2016

02-Jul-2015 - MHRA, the UK pharma regulator, says its staff cuts over the next three years will not impact its work with pharma.

Hospira's Vizag plant begins sterile production following US FDA approval

02-Jul-2015 - Hospira has begun commercial production at a sterile injectable plant in India hit with several 483 forms after the US FDA deemed the site ‘acceptable.’

New logo will help patients tell legit EU web pharmacies from illegal sites says EC

01-Jul-2015 - Europeans who want to fund organised crime can now do so more easily by buying medicines from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.

US FDA extends track-and-trace deadline for pharmacies

01-Jul-2015 - The US FDA says has granted a four month amnesty to pharmacies which do not comply with new track-and-trace regulations that come into force today.

Sequenom case leaves pharma confused over patent law

30-Jun-2015 - US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

ICH clarifies Q7 guidance on API GMP manufacturing

30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer  (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.

Health Canada asks importers to quarantine Polydrug APIs over data concerns

29-Jun-2015 - Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.

Trial data: charity hits back at CRO’s anti-transparency bid

25-Jun-2015 - Charity Sense About Science is attempting to intervene in a UK CRO’s legal action against trial transparency.

US FDA publishes API-salt naming policy

24-Jun-2015 - Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).

US FDA & INTERPOL seize fake meds from 1,000 websites

24-Jun-2015 - The US FDA has seized illegal medicines and medical devices sold by more than 1,050 websites.

BIO 2015

TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma

23-Jun-2015 - Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.

US FDA: Generic pills must look similar to reference drugs to minimize patient safety risk

23-Jun-2015 - Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.

BIO 2015

Does second prequalified vaccine mark China as ‘true global player’?

23-Jun-2015 - China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015. 

EU pharma industry a step closer to fake fighting drug repository

23-Jun-2015 - Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.

News in brief

Dutch pharma policy NGO Health Action International opens Brussels office

23-Jun-2015 - Health Action International (HAI) has set up an office in Brussels, Belgium in a bid to further influence European pharmaceutical policy and improve access to medicines and public health.

|Dispatches from ACHEMA

Regulators play catch up with ever more complex manufacturing processes

18-Jun-2015 - EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.

Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

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