The Japanese government is eager to jumpstart its generic-drug market, but changes must come first.

Taiwan sees to bring its intellectual property laws and enforcment into better alignment with international standards.

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.

This month, Frankfurt readies itself for the descent of more than 27000 additional visitors, as it plays host to the world's largest chemical engineering exhibition and congress - Achema 2009.

A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.

As the pharma industry desperately seeks to cut costs and streamline production, a new breed of CMO is growing in Europe. Find out how today's CMO is capitalizing on pharma's plant closures and divestments.

Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...

Global market research firm IMS Health issued a disappointing report last week regarding the state of the pharmaceutical market.

The Pharmaceutical Research and Manufacturers of America released a statement this week in response to recent media reports regarding the amount of pharmaceutical ingredients being discharged by manufacturing facilities into the environment.

The US Food and Drug Administration has agreed to address some core industry questions regarding the changes made to US Pharmacopeia General Chapter <467> in July 2008.

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).

The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).

Pharmaceutical giants GlaxoSmithKline (GSK) and Pfizer announced on April 16, 2009 that they are joining forces to create a new HIV-focused drug company.

On April 2, the Health Products and Food Branch of Health Canada and EU (consisting of the European Commission [EC] and European Medicines Agency [EMEA]) released "Implementation Plan for Regulatory Cooperation on Medicinal Products."

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow.

Last week, Johns Hopkins Medicine (JHM) adopted a new policy to protect patients by limiting the influence of pharmaceutical marketing on faculty and physicians? decisions.

Also, Sanofi-aventis acquires Medley and Laboratorios Kendrick; Eli Lilly's Cook to retire from board; more...

In late March, the US Food and Drug Administration sent warning letters to nine companies to stop manufacturing 14 unapproved narcotic drugs. Less than two weeks later, on Apr. 9, the agency amended those letters when it realized that one particular unapproved opioid (a high concentrate of morphine sulfate oral solution) is desperately needed by patients.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the April 2009 edition from Buzdar and Kaeser.

ATSM and ICH approaches, in place of traditional qualification or integrated commissioning and qualification (C&Q) using impact assessment, can make projects and processes more efficient and help facility owners and designers ensure compliance, quality, and safety when defining acceptance criteria for their critical process systems and equipment.

Many drugmakers have begun to evaluate and improve their manufacturing operations to become more economically and environmentally sustainable.

Pfizer outlined the progress of its late-stage pipeline last week and announced this week plans to separate its research activities into two organizations, one focused on small molecules and the other on biologics, pending the closure of its pending acquisition with Wyeth.

Following several years of debate, the Senate Judiciary Committee voted 15?4 last week to approve a comprise patent reform bill, the "Patent Reform Act of 2009" (S. 515).

The Pharmaceutical Research and Manufacturers of America (PhRMA) elected David Brennan, CEO of AstraZeneca, as board chairman.

Also, Genzyme and Bayer HealthCare form agreement; FDA releases draft guidances; TransMolecular appointed Robert Radie president and CEO

The US Food and Drug Administration issued 14 untitled letters last week to pharmaceutical companies in violation of the Federal, Food, Drug, and Cosmetic Act for publishing misleading and misbranded information about their drug products online.