Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.
UDG Healthcare has acquired two healthcare-focused firms, expanding its global footprint and service offerings – including those in health economics and outcomes research – in a deal worth up to $82.4m.
In the days of personalised medicine, 3D printing and nanotechnology, consultant David Chesney says regulators must “keep pace” to redefine current good manufacturing practice.
Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.
A proposed Final Rule, which would delay the implementation of the revised Common Rule, comes as a surprise to many in the institutional review board (IRB) community, says WCG compliance VP.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
UK regulators have banned Apotex Research Private Limited from shipping drugs made at its plant in Bangalore, India to the EU after inspectors raised concerns about the potential for cross contamination.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.
Legal loopholes and poor enforcement let criminals in China divert APIs for illegal drug production according to a US congressional committee which says the country is fast becoming the major global supplier of crystal meth precursors.
With deadlines around the corner, companies are beginning to plan their serialization initiatives – a process defined by regulatory changes, says Antares Vision.
A newly established trade group has invited chemical manufacturers to apply for membership and announced plans to look at API and pharma-related issues.
In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and...
The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).
A quality assurance audit is as beneficial to the CMO as it is to the sponsor selecting a third-party manufacturer, according to an ex-Merck Serono and MHRA consultant.
The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
Sale of medicines on trains and planes is just one reform being considered in a series of simplification measures aimed at increasing industry efficiency by the MHRA.
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.
The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its proposed rule from 2009.
The cost of proposed new tests designed to ensure levothyroxine tablet quality is a small price to pay for manufacturers to ensure patient safety says the UK MHRA.
Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.
New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
PPMA is fearful that the Government of Pakistan’s recent call for more foreign investment in the local pharma sector will go unheard because the industry is already overcrowded.
Animal welfare watchdog group, Stop Animal Exploitation Now (SAEN), has released documents which, it claims, provide evidence that CRO MPI Research has been operating in violation of the US Animal Welfare Act.
Adoption of electronic submission by regulators around the world is good news for drugmakers’ efforts to access emerging markets says industry expert Kate Wilber.
Tracking “non-content” metadata is an important part of any pharmaceutical submission, yet many drugmakers fail to take an integrated approach to the task according to regulatory expert Kate Wilber.
The FDA is to establish current good manufacturing practice (cGMP) requirements for combination products to eliminate inconsistencies that could affect product safety and public health.
Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.
The International Pharmaceutical Excipients Council (IPEC) – currently represented by divisions in Europe, the Americas, Japan and China – could see sister organisations open up in Latin America and India in the coming months.
IT specialist ComplianceControl has a introduced a comprehensive
new directory of compliance regulations with precise and accessible
information that can be used to assist pharmaceutical companies in
co-ordinating their corporate...
AssurX have launched a software process for document control, which
will enable pharmaceutical manufacturing companies to streamline
their approach to monitoring safety issues and overall quality
control efforts.
A federal US judge set a precedent last week in ruling against the
US Food & Drug Administration (FDA) in a four-year dispute
against Utah Medical Products.
