Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
SRF Limited has unveiled plans for a second chloromethane plant just two months after India imposed anti-dumping tariffs on Chinese and Russian imports.
Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.
Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
Pharmaceutical and chemical manufacturers may have to wait until 2017 to see the benefits of the Transatlantic Trade and Investment Partnership, VP of SOCMA (Society of Chemical Manufacturers and Affiliates) told attendees at InformEx in New Orleans.
Roselabs Bioscience has invested $67M into a pre-filled syringe facility in India and is exploring the option of exporting the products to 35 countries in unregulated markets in southeast Asia, Latin America and Africa.
The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe on route to Africa and Latin America, according to reports.
ACTA was finalised last week but controversies remain, with research warning it could “create significant barriers to international trade, especially in generic medicines”.
in-PharmaTechnologist presents an overview of the UK pharma sector, using interactive maps and graphs to give an insight into its composition and how it has changed in recent years.
It is “legislative madness” to allow reimportation in the US, according to the chair of EAASM who spoke at AAPS about Europe’s “porous supply chain” and how it could affect the standard of medicines in the States.
Shipments of drugs that do not violate patent rights in the exporting or importing countries should not be seized in transit or labeled as counterfeit, as occurred recently, according to health advocates.
Despite a lift of the ban on biological sample transportation out
of Russia, the country's clinical research industry is still in the
dark on the new rules to control export of such materials.
Efforts by Pakistan to build a pharmaceutical sector to rival that
of neighbouring India are being undermined by regulatory
interference, according to representatives of the domestic drug
industry.
The Ministry of Commerce in China has that it plans to review the
five-year programme of anti-dumping duties it set on catechol
imports from the European Union.
In Norway, the Supreme Court has concluded that the packaging
designused by the local subsidiary of parallel importer Paranova
does notinfringe Merck & Co's trademarks.
The US Food and Drug Administration has started a new comment
period on its bioterrorism regulations - designed to safeguard the
national food supply - which will have a significant impact on
companies importing pharmaceutical excipients...
China's packaging industry is currently undergoing a growth rate
that is set to turn the sector into one of the country's leading
industries, report Simon Pitman and Phil Taylor.
Compared with European and US chemical companies, most domestic
Chinese chemical enterprises have remained technologically
challenged with productivity lagging behind international levels.
Companies involved in the parallel trade of pharmaceuticals have
been boosted by a court ruling which gives them the right to re-box
products shipped into the UK from another country in the European
Union.
