By Guy Villax, Board Member, EFCG; Chief Executive, Hovione
In my 25 year career in the pharmaceutical industry, Rx-360 is the very first initiative that I know of that aims to bring together every segment of the industry and every link of its supply chain: innovators and generics, big and small, producers of every type of formulation, makers of APIs, intermediates and excipients, middlemen and regulators - so to its American founders we send our congratulations and offer support from this side of the Atlantic.
APIC (Active Pharmaceutical Ingredients Committee) and EFCG (European Fine Chemicals Group) are trade associations that represent over 200 manufacturers of APIs, intermediates and excipients - companies that meet cGMPs and support Rx-360.
In Europe producers have raised the alarm of sub-standard APIs and rogue players for over 10 years...
Economically Motivated Adulteration
By Martin VanTrieste
On May 1, 2009, the FDA sponsored a public workshop on Economically Motivated Adulteration in College Park, Maryland. The purpose of the meeting was to stimulate and focus a discussion on ways in which food (including dietary supplements and animal food), drug, medical device, and cosmetic industries, regulatory agencies and other parties can better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risks. FDA invited interested individuals, organizations and other stakeholders, including industry representatives to present information pertaining to predicting and preventing economically motivated adulteration.
Rx-360 Survey Results: Supplier Requested Fees for the Opportunity to Conduct an On-site Audit
The response rate to the first Rx-360 survey, Supplier Requested Fees for the Opportunity to Conduct an On-site Audit, was excellent with a 50% response rate. There are some interesting data that can be ascertained from the survey...
June 3 - 4 Seminar: Global Supply Chain Integrity and Anticounterfeiting (ISPE)
The integrity of the pharmaceutical supply chain is becoming the focus of increasing concern and scrutiny. The supply chain is becoming more complex, the number of environmentally sensitive products is rising sharply and the sophistication of counterfeiters is alarming.
Consequently, the industry is facing increasing legislative scrutiny and guidance on ensuring the quality of its products throughout their entire lifecycle. The FDA, the European Commission, and WHO have both issued recent guidance documents to address these challenges while regulatory agencies around the world are in the process of reviewing their regulations in an attempt to assure safe, efficacious drug supply from the manufacturer to the final delivery to the patient.
Click here for more information on this seminar
News- 14 May 2009
Overseas API vendor qualification under US FDA spotlight says H&H
By Gareth Macdonald, www.in-pharmatechnologist.com
US drug firms' qualification of overseas API vendors will be subject to increased FDA scrutiny in the coming years according to a new industry report by analysts Hogan & Hartson (H&H).
News Flash - 05 May 2009
Draft US Senate Drug Device Accountability Act of 2009 - Rx-360 Analysis
As a service to our members, a small team, led by Barbara Unger, has completed an analysis of the draft legislation from US Senators Reid, Kennedy and Grassley entitled S.882 Drug Device Accountability Act of 2009.
This analysis is in a Microsoft PowerPoint presentation format and can be downloaded, along with the text of the draft legislation, by registered users of the Rx-360 website at www.rx-360.org.
You must first login to the web page, then go to the tab entitled "Community" and click on the "Documents" section. Then you can download the documents you want to view.
News Flash - 03 May 2009
Warnings Over Counterfeit Swine Flu Drugs
A shortage in any drug provides opportunities for unethical and criminal elements to enter the supply chain. This was a contributing factor during the heparin tragedy. Now with global fears of a pandemic flu, we must stop, think and act to prevent and / or detect possible counterfeiting of various antiviral agents and economic adulteration of their raw materials.
The Royal Pharmaceutical Society of Great Britain (RPSGB) has issued a warning about the dangers of buying potentially counterfeit medicines to treat swine flu over the internet...
News- 29 April 2009
SFDA's Commissioner Shao Mingli met with KFDA's Commissioner Yeo-Pyo Yun
News- 27 April 2009
New Head of Inspections Sector appointed
The European Medicines Agency has appointed Fergus Sweeney as the new Head of its Inspections Sector.