France’s National Agency for Medicines and Health Products Safety (ANSM) has suspended the manufacturing operations at French biotech company Theravectys’ Villejuif, France-based site for one year (beginning last September) following an inspection in November. ANSM said in a report released Monday that its inspection from 17 to 20 November 2015 of the Paris-based Pasteur Institute spinoff raised 45 deficiencies, including five critical and 17 major deficiencies. The comp...

[Editor's note on 2/19/16: FDA spokesman Stephen King has since offered additional comment though he could not confirm whether or not this comment applies to Zhejiang Hisun or what the company has done to ensure that the API it's allowed to send to the US is not manufactured in the same way as the APIs that are banned from entering the US .  "When FDA exempts certain drugs from an import alert due to shortage concerns, the agency also often requests the manufacturer to ...

After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...

This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...

The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...

Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found. Background In the US, drug products are primarily overseen by two federal agencies: FDA and DEA. The former regulates drugs in accordance with their efficacy, safety and quality. For example, FDA might approve a...

The Canadian Government will soon release new regulations on drug shortage reporting, it has announced . The regulations will require companies to report drug shortages on a new, independently run website. Background Drug shortages occur when there is not enough of a product to meet the needs of patients. Due to the complexity of the supply chain for drugs, shortages can occur for a variety of reasons, including manufacturing and distribution issues or unforeseen spike...

The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability. In an announcement in the 9 December 2014 edition of the Federal Register , DHHS said it was issuing a new declaration that would "provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration." Protection f...

The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...

The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...

A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines. Background FDA has since 2009 been advocating for a rule which would require all mandatory postmarketing safety reports to be submitted to the agency in electronic form (instead of paper), saying that the change could allow it to better process, review and archive the documents. The r...