Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

In late October, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. As already reported by Pharmaceutical Technology, a major success of the meeting was the adoption of several annexes to the Q4B guideline on pharmacopeial texts (see back 

).

ICH, which will celebrate its 20th anniversary in 2010, has come quite a long way since it was founded. Established in 1990 as a venue for pharmaceutical regulators and industry experts around the world to discuss how to harmonize the safety, quality, and efficacy of medicinal products, the conference has adopted and begun to implement more than 60 guidelines and guideline annexes. The key to ICH’s success is implementation, says Justina A. Molzon. “ICH owes its  success as a harmonization initiative to a very dedicated Secretariat and the efforts of its expert working groups to generate science-based consensus guidelines ” she says. 

 Molzon, a captain in the US public health service commissioned corps, is the associate director for international programs at the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). She is CDER's ICH steering committee representative and also serves on ICH's  Global Cooperation Group (GCG) and independent Regulators Forum.

Molzon compared ICH with two other global harmonization bodies, the World Health Organization and the Pan American Network on Drug Regulatory Harmonization (PANDRH), as part of a recently published book by Springer, Pharmaceutical Stability Testing to Support Global Markets. Although ICH represents what Molzon calls the “corporate” version of the three bodies, its advantage is that it now has “a common regulatory language in the common technical document (CTD) and input that other countries can use. We are at a point where ICH can focus on discussing implementation and dissemination of well-established scientific guidances with interested countries that were not originally involved in the ICH process thereby sharing perceived benefits with regulatory colleagues.”

 The founding parties and steering-committee members of ICH include: the EU, the European Federation of Pharmaceutical Industries and Associations, Japan’s Ministry of Health, Labor, and Welfare; the Japan Pharmaceutical Manufacturers Association, FDA, and the Pharmaceutical Research and Manufacturers of America (PhRMA). But with the pharmaceutical industry expanding across the entire globe, the conference established in 1999 the Global Cooperation Group as a subcommittee to share ICH information and guidelines with countries and groups that are not official parties to the ICH organization.

GCG members are able to attend ICH meetings at the steering-committee and working-group level. Members include the Asia-Pacific Economic Cooperation, the Association of Southeast Asian Nations, the Gulf Cooperation Countries, PANDRH, and the Southern African Development Community. 

The GCG is essentially a “clearinghouse for training,” says Molzon. For example, the group recently put together a training program in Beijing on good manufacturing practices and quality implementation (ICH Q8, Q9, and Q10). “We make sure that things are done multilaterally so that everyone has a role to play,” she adds.

Despite the existence of the GCG, ICH regulators decided more was needed to take harmonization to the next level. So in June 2008, a Regulators Forum was established. Although the forum is not technically part of ICH, its meetings are held in conjunction with ICH meetings and the same groups that participate in the GCG also participate in the Regulators Forum. In addition, individual countries are represented in the forum, including Australia, Brazil, China, Chinese Tapei, India, Korea, Russia, and Singapore.

“Regulators only can talk about how they are implementing things, discussing what they do, how they trained their staff, and so forth,” says Molzon about the forum. Currently, forum participants are focusing on how they conduct reviews within their own regulatory bodies. Ever since ICH adopted the CTD-and now the electronic CTD-for filings in 2000, it makes sense that regulators review the information in a similar way as well, explains Molzon. 

Looking ahead, both the GCG and Regulators Forum would like to bring in additional countries to extend the reach of harmonization. If a country is interested in implementing ICH guidelines and requests to be involved, they can be, says Molzon.

Articles

Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, ICH has benefited regulatory authorities.

FDA's Justina A. Molzon on ICH and Harmonization

The FDA has issued 22 Warning Letters to website operators as part of its International Internet Week of Action, a week-long international effort aimed at curbing illegal actions involving medical products. Twenty-four countries participated in the special operation, which focused on four key areas:

increasing public awareness about the dangers and risks associated with purchasing drugs and medical devices online

identifying producers and distributors of counterfeit and illegal pharmaceutical products and medical devices

targeting these individuals and businesses with civil or criminal action

seizing counterfeit and illegal products and removing them from the supply chain.

"Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies," said FDA Commissioner Margaret A. Hamburg in a 

. "Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers."

The FDA’s Office of Criminal Investigations, Center for Drug Evaluation and Research, Office of Regulatory Affairs, and Office of Enforcement were involved in the effort, which targeted 136 websites that "appeared to be engaged in the illegal sale of unapproved or misbranded drugs to US consumers", according to the release. The effort was sponsored by the International Criminal Police Organization, the World Health Organization's International Medical Products Anticounterfeiting Task Force, the Permanent Forum on International Pharmaceutical Crime, and the national health and law enforcement agencies of the 24 participating countries. 

Report: Online Drug Brand Abuse on the Rise 

FDA’s Recent Actions Against Illegal Prescription Drug Flow

The FDA has issued 22 Warning Letters to website operators as part of its International Internet Week of Action, a week-long international effort aimed at curbing illegal actions involving medical products.

FDA targets illegal pharma websites

The US Food and Drug Administration has issued 22 Warning Letters to website operators as part of its International Internet Week of Action. The week-long international effort is aimed at curbing illegal actions involving medical products, according to a Nov. 19 agency press release. Twenty-four countries participated in the special operation, which focused on four key areas, says the 

Increasing public awareness about the dangers and risks associated with purchasing drugs and medical devices online

Identifying producers and distributors of counterfeit and illegal pharmaceutical products and medical devices

Targeting these individuals and businesses with civil or criminal action

Seizing counterfeit and illegal products and removing them from the supply chain.

“Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies,” said FDA Commissioner Margaret A. Hamburg in the release. “Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.” 

  FDA’s Office of Criminal Investigations, Center for Drug Evaluation and Research, Office of Regulatory Affairs, and Office of Enforcement were involved in the effort, which targeted 136 websites “that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to US consumers,” according to the release. The effort was sponsored by the International Criminal Police Organization, the World Health Organization's International Medical Products Anticounterfeiting Task Force, the Permanent Forum on International Pharmaceutical Crime, and the national health and law enforcement agencies of the 24 participating countries. None of the websites were for pharmacies located in the US or Canada.

Report: Online Drug Brand Abuse on the Rise

The US Food and Drug Administration has issued 22 Warning Letters to website operators as part of its International Internet Week of Action.

International Campaign Targets Illegal Pharmaceutical Websites; FDA Issues 22 Warning Letters

The international pharmaceutical supply-chain consortium Rx-360 has launched in Europe; with more than 135 industry and regulatory representatives attending to discuss the global impact of counterfeit drug products. Attendees also focused on the challenges involved in creating a nonprofit, voluntary consortium that will focus on shared supplier audits and disseminating supply-chain information and standards throughout the world.

The consortium held a US-launch meeting for pharmaceutical and biotechnology companies, suppliers, and regulators in 

Another European-based initiative from the growing consortium is its new homepage widget, which features a searchable database of suppliers that have been certified by the European Directorate for the Quality of Medicines and Healthcare (EDQM). Established in 1994, the EDQM program specifically certifies the suitability of the monographs in the 

 to adequately control the quality of a substance from the source. 

 spoke to the director of EDQM, Susanne Keitel, and the head of Rx-360, Martin Van Trieste, among others, as part of a unique roundtable earlier this year. The speakers’ full talks are available as a 

The international pharmaceutical supply-chain consortium Rx-360 has launched in Europe; with more than 135 industry and regulatory representatives attending to discuss the global impact of counterfeit drug products.

Rx-360 takes on Europe

 The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance. According to an Rx-360 release, meeting participants focused on the global impact of counterfeit drug products and discussed the challenges involved in creating a nonprofit, voluntary consortium that will focus on shared supplier audits and disseminating supply-chain information and standards throughout the world. The consortium held a US-launch meeting for pharmaceutial and  biotechnology companies, suppliers, and regulators in June 2009 in Washington, DC (see back story, 

Pharma Industry Consortium Rx-360 Tackles Supply-Chain Security

  Another European-based initiative from the growing consortium is its new homepage widget featuring a searachable database of suppliers that have been certified by the European Directorate for the Quality of Medicines and Healthcare (EDQM). Established in 1994, the EDQM program specifically certifies the suitability of the monographs in the 

 to adequately control the quality of a substance from the source.

 spoke to the director of EDQM, Susanne Keitel, and the head of Rx-360, Martin Van Trieste, among others, as part of a roundtable earlier this fall. The speakers’ full talks are available to listen to in 

Is Industry Ready to Share Supplier Audits? Rx-360 Takes a Shot

 (PharmTech November 2009 cover story)
 
  

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance.

Rx-360 Takes on Europe, Talks to PharmTech About Shared Audits

Novartis (Switzerland) plans to invest $1 billion during the next 5 years to increase R&D activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.

"We are confident that our expanded investment in R&D will result in innovative therapies for patients in China and other countries nurtured by the growing scientific excellence in China," said Novartis Chairman and CEO Daniel Vasella, in a company 

. "We are also pleased to contribute to the Shanghai government's aim to establish the city as the premiere R&D center for China's bio-medicine industry by 2012, as Novartis is committed to investing to further the Chinese government's strategy for stimulating economic growth, stability and enhancing the livelihood of the Chinese people."

Specifically, the Chinese government aims to provide all citizens with access to affordable, basic healthcare by 2020, involving a $124-billion investment during the next 3 years. Other government plans include improving the country’s information technology systems, and strengthening the nation’s pharmaceutical production quality and safety.

The Novartis Institute for BioMedical Research in Shanghai, located in Zhangjiang High-tech Park, specializes R&D of small-molecule and biologics for diseases prevalent in China. The new expanded institute will be located in a new state-of-the-art campus in Shanghai and will increase collaboration with other Chinese institutes. The institute will work on analytics and biomarkers, 

 pharmacology, protein production, characterization and scale-up screening, chemistry and proteomics, genomics and imaging. The center is expected to be the largest comprehensive R&D center in China, with associate positions increasing from 160 to nearly 1000.

In related news, Novartis is investing $250 million in a new global technical center in Changshu (China) for technical R&D as well as API manufacturing.