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Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree

Regulators are highlighting a better understanding of protein glycosylation – its linkage to product safety and efficacy and what constitutes appropriate characterization – as an important element in developing a more internationally-aligned approach to regulating biotech products....

Alleged Use of “Gutter Oil” to Produce Antibiotic Intermediate in China Probed

The government of Central China’s Jiaozuo city sent a team in early September to a subsidiary of Joincare Pharmaceutical Group to investigate allegations that the firm is manufacturing an antibiotic intermediate using reprocessed cooking oil, called “gutter oil,” China Daily reports. China’s State Food and Drug Administration (SFDA) announced that it would investigate the truth […]

Regulatory Pathways Are Opening Up Globally for Biosimilars

Implementation of biosimilar legislation in India and Brazil, an increase in drug review staff in Japan, and the publication of a draft monograph for monoclonal antibodies to be included in the Chinese pharmacopeia are among the regulatory efforts taking place across the globe that expand the opportunities for biosimilars....

China Projected to Become Major Global Vaccine Supplier with WHO Imprimatur and Overhauled Regulatory Infrastructure

The World Health Organization (WHO) certification of China’s FDA (SFDA) as a “competent authority,” and the quality regulatory upgrades the WHO imprimatur reflects, have opened the door for China to become a major player in the global marketplace for vaccines, WHO Director-General Margaret Chan said at the 65th World Health Assembly held in late May in Geneva, Switzerland....

Russia Prefers Release Testing for Imported Drug Products to be Performed in Europe

Industry and EMA officials are reporting that for products marketed both in the EU and in Russia, Russian regulatory officials prefer release testing to be done in the EU. The issue of release testing for drug products going to Russia received attention during a panel discussion at a “European GMPs and the Role of the […]

Bolus of FDA Warning Letters to Foreign Manufacturers Spans Regions and Product Types

During a two-week period in late February and early March, FDA’s drug compliance office issued a bolus of six warning letters to foreign manufacturers that span across regions and product types, including two each on active pharmaceutical ingredients (APIs), over-the-counter (OTC) solutions and injectables....

SFDA Completed Ten GMP Inspections of Overseas Manufacturers in 2011

In 2011, China’s State Food and Drug Administration (SFDA) completed ten GMP inspections of firms in the US, the EU, South Korea and India that manufacture vaccines, APIs, biologics, and oral solid dosage forms and sell their products in China. The overseas inspections were announced last October (IPQ “The News in Depth” Nov. 10, 2011), […]

USP Announces Memorandum of Understanding with South Korean FDA

USP and the South Korea Food and Drug Administration (KFDA) have signed a memorandum of understanding (MoU) that seeks to identify areas of collaboration between the organizations, raise awareness of the importance of the quality and safety of medicines, and identify areas of mutual interest. KFDA Commissioner Hee-Sung Lee and USP CEO Roger Williams signed […]

New Ranbaxy Site in India Begins Shipping Generic Lipitor to the US

Ranbaxy Laboratories announced in early April that the company has begun exporting its generic version of Lipitor (atorvastatin calcium) oral tablets to the US market from its new “Mohali” manufacturing facility located in Punjab, India. In the first quarter of 2012, the company received approval from FDA to manufacture and market atorvastatin 10mg, 20mg, 40mg […]

Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH

Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities....
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