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  • Regulatory NewsRegulatory News

    FDA to Drug Compounders: Inspection Changes Coming in August

    The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up. For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators wi...
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    Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections. The news of the progress comes as both agencies continue to observe their counterparts’ inspections on an ongoing basis. Emer Cooke, head of international affairs at the EMA, told Focus in an exclusive interview that both sides have “progressed quicker than w...
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    Two Indian Contract Pharma, API Manufacturers Refuse FDA Inspections

    The US Food and Drug Administration (FDA) this week added contract manufacturer Cheryl Laboratories’ Navi Mumbai-based manufacturing facility and active pharmaceutical ingredient (API) and intermediate manufacturer Phalanx Labs’ Visakhapatnam-based site to its list of foreign firms that are banned from shipping product to the US because they refused FDA inspections. FDA’s “Red List” identifies firm(s) that have offered FDA-regulated articles for import into the US and ...
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    CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

    China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA. The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the rat...
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    Asia Regulatory Roundup: Serious Injuries Linked to Devices in China Almost Double (31 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Reports Drop in Manufacturers Achieving Satisfactory Compliance Australia’s Therapeutic Goods Administration (TGA) has reported a sharp drop in the proportion of domestic manufacturers achieving satisfactory levels of compliance during inspections. In the second half of 2015, no more than 81% of inspections identified satisfactory levels of compliance, compared to...
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    Asia Regulatory Roundup: CFDA Releases New Guidance on Device Trial Inspections (24 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Releases Clutch of Draft Medical Device Clinical Trial Texts China Food and Drug Administration (CFDA) has released a handful of draft documents about clinical trials of medical devices. The documents, which detail the process for on-site inspections and the products that are exempt from studies, continue the ongoing overhaul of the regulation of medical devices in Chi...
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    Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Updates Process for Closeout of On-Site GMP Inspections Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection r...
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    Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Hepatitis C, Cancer Drugs on Regulatory Approval Fast Track China has granted priority review status to a clutch of drugs being developed by Western companies. The products affected by the actions include the expensive hepatitis C drugs from Gilead Sciences and other manufacturers that have transformed treatment of the disease in the West. Versions of Gilead’s b...
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    FDA to Pharma Companies: Indian CRO’s Clinical and Bioanalytical Studies are Unacceptable

    Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. Following its r...
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    FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

    Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. On Wednesday, FDA added Xinxiang Pharmaceutical Co. and  Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are sub...
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    FDA: Foreign Device Inspections on the Rise

    Newly released data shows the US Food and Drug Administration (FDA) conducted fewer medical device quality systems inspections in 2015 compared to recent years, while the number of foreign inspections increased to their highest number in a single year. In total, FDA conducted 2,104 inspections in 2015, down from 2,213 in 2014, approximately five to seven percent fewer than it conducted between 2011 and 2014. Quality Systems Inspections, 2008-2015 (Source: FDA) Nearl...
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    US FDA Inspections in China: An Analysis of Form 483s from 2015

    As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India. A Focus review (thanks to use of the Freedom of Information Act (FOIA)) of eight FDA Form 483s for Chinese manufacturers i...