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News headlines

“There are units that are doing first-in-human studies that frankly have no business doing them”

DIA: Calls for set standards in Phase I studies following Bial trial tragedy

29-Jun-2016 - Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.

US FDA slams two Chinese API makers for quality systems and data issues

29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

Swissmedic ramps up ad hoc inspections in 2015

28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.

Brexit: Indian firms worried but Big Pharma and EMA remain positive for now

Worried and bewildered: Brexit sparks uncertainty for Indian pharma in Europe

28-Jun-2016 - Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.

Serialisation regulations to impact all corners of pharma, says Recipharm

27-Jun-2016 - The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.

DIA 2016

'Now is the time to include Japan' says Parexel

24-Jun-2016 - Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.

BIO 2016

Commissioner Califf commits to tackling staffing issues at US FDA

23-Jun-2016 - Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.

India to rewrite 75-year old drug laws with an eye on business, biologics and devices

23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.

update

Three drug wholesalers have failed GDP checks according to Czech regulator

22-Jun-2016 - Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.

Opko extended-release kidney disease drug approved after Catalent 483 delay

22-Jun-2016 - The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

Comparing ClinicalTrials.gov and FDA review for accuracy and completeness

20-Jun-2016 - Clinical trial sponsors are required by law to report results to ClinicalTrials.gov; however it’s not clear if these posts are complete and accurate.

News in brief

Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection

20-Jun-2016 - The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.

Phalanx Labs banned from shipping APIs to US after refusing inspection

17-Jun-2016 - The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.

Indian drug advisory board backs proposed API import license fee hike

16-Jun-2016 - A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).

News in brief

CDSCO working on new Drug and Cosmetics Act; calls for input

16-Jun-2016 - Indian regulator CDSCO is developing a new Drug and Cosmetics Act that is more in keeping with the modern pharmaceutical industry.

correction

The strife of Pii: UK MHRA finds GMP deviations at two facilities

15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).

Austin Biotechnology hit with US FDA warning at Taipei facility

15-Jun-2016 - The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.

update

Prosecutors examining fatal BIA-10-2474 trial start manslaughter investigation

14-Jun-2016 - French authorities have started a manslaughter investigation in connection with a Ph I trial  conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised.

CDSCO renews API firms' 'written confirmations' days after industry raises trade concerns

13-Jun-2016 - CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.

updated

MHRA says Akums' cannot prove progesterone made at Hardiwar plant is sterile

13-Jun-2016 - The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.

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