Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

The US Food and Drug Administration opened another foreign office on Dec. 15, 2009, this time in Mexico City. The new post marks the agency’s third location in Latin America and its tenth international office to open during the past 13 months, according to an FDA 


 “The opening of this office represents an important step as we redesign our product safety strategy,” said FDA Commissioner Margaret A. Hamburg, in the release. Mexico City employees will work with their Mexican government counterparts to harmonize regulations and develop other collaborative initiatives such as information sharing.


 “FDA staff will work with industry in Mexico as well,” said Murray M. Lumpkin, deputy commissioner for international programs in the release. “Their activities will include providing technical advice and working with government agencies and the private sector to develop certification programs.”


 Other FDA international posts are in China, India, Europe, and Latin America. Other Latin American offices are located in Santiago, Chile, and San José, Costa Rica.


, “HHS to Open Offices Abroad, Starting with China.”

Articles

The US Food and Drug Administration opened another foreign office, this time in Mexico City.

FDA Opens Mexico City Office

The Government Accountability Organization (GAO) has recommended that the FDA Commissioner develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs (OND) to the Office of Surveillance and Epidemiology (OSE) to help address weaknesses in the agency’s oversight of postmarket drug safety. The plan should include timefames and steps to ensure resources are properly aligned, says a 

The GAO has made several recommendations regarding the FDA’s postmarketing work over the past few years, including a 2006 report that the agency better define the roles of the OND and OSE offices. In this new report, GAO examines what the FDA is doing to improve its decision-making regarding the safety of marketed drugs, its access to data on drug safety issues and its capacity to fulfil its postmarket drug safety workload.

Overall, the GAO notes that although the FDA is "beginning to address previously identified weaknesses in its oversight of postmarket drug safety issues…challenges remain." Some positive steps include the agency’s Safety First Initiative, which involves formalizing interactions between the OND and OSE, and providing the OSE with added responsibilities. To date, the FDA has transferred premarket review responsibility from the OND to OSE, and plans to transfer to additional postmarket responsibilities (for reviewing certain types of drug safety studies).

"The FDA is also revising its programme for resolving scientific disputes, but these changes have not increased its independence, as GAO recommended," explained a previous report.The FDA also plans to implement new systems in 2010 to improve the timeliness, quality and analysis of reports of adverse events associated with human drug use; to increase  funding for contracts with private companies; and to continue developing the Sentinel System  a network of external data providers intended to enhance drug safety surveillance, among other efforts.

Because of the agency's huge workload, however, it has been difficult for the OND and OSE staff to meet their responsibilities in full, says the GAO report. An increase in staff is needed (perhaps double the staff for OSE by fiscal year 2011), says the GAO. In addition, the agency needs help fulfilling several committee vacancies to help in its decision-making.

The Government Accountability Organization (GAO) has recommended the FDA Commissioner to develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs (OND) to the Office of Surveillance and Epidemiology (OSE) to help address weaknesses in the agency?s oversight of postmarket drug safety.

FDA recommended to continue work on postmarket safety issues

 released Dec. 9, 2009, the Government Accountability Office (GAO) recommended that the US Food and Drug Administration Commissioner develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs (OND) to the Office of Surveillance and Epidemiology (OSE) to help address weaknesses in the agency’s oversight of postmarket drug safety. The plan should include timefames and steps to ensure resources are properly aligned, says the report.

GAO has made several recommendations regarding FDA’s postmarketing work over the past few years, including a 2006 report that the agency better define the roles of the OND and OSE offices. In this new report, GAO examines what FDA is doing to improve its decision-making regarding the safety of marketed drugs, its access to data on drug safety issues, and its capacity to fulfill its postmarket drug safety workload.

 Overall, GAO notes that although “FDA is beginning to address previously identified weaknesses in its oversight of postmarket drug safety issues…challenges remain.” Some positive steps include the agency’s Safety First Initiative, which involves formalizing interactions between OND and OSE and providing OSE with added responsibilities. To date, FDA has transferred premarket review responsibility from OND to OSE and plans to transfer to additional postmarket responsibilities (for reviewing certain types of drug safety studies). 

“FDA is also revising its program for resolving scientific disputes, but these changes have not increased its independence, as GAO recommended” in a previous report. FDA also plans to implement new systems in 2010 to improve the timeliness, quality, and analysis of reports of adverse events associated with human drug use; to increase funding for contracts with private companies; and to continue developing the Sentinel System, a network of external data providers intended to enhance drug safety surveillance, among other efforts. 

Yet, because of the agency’s huge workload, it has been difficult for OND and OSE staff to meet their responsibilities in full, says the GAO report. An increase in staff is needed (perhaps double the staff for OSE by fiscal year 2011), says GAO. In addition, the agency needs help fulfilling several committee vacancies to help in its decision-making. 

The Government Accountability Office recommended that the US Food and Drug Administration Commissioner develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs to the Office of Surveillance and Epidemiology to address weaknesses in the agency's oversight of postmarket drug safety.

GAO Recommends FDA Continue Its Work on Postmarket Safety Issues

The EMEA has unveiled several changes to the organization, including a new structure and visual identity.

One primary structural change involves integrating human pre- and post-authorization activities into one unit, “to guarantee seamless lifecycle-management of medicines,” according to a 

. Also, a group will be dedicated to the management of product data and documentation to help improve the efficiency of data-management processes throughout the agency.

This is the second time the EMEA has undergone restructuring. Established in 1995, the agency’s “responsibilities and tasks have grown, giving it a stronger role in the protection of public and animal health in Europe,” according to the press statement. “All of this has been underpinned by the creation of additional scientific committees and advisory groups, which bring with them the need for enhanced coordination and support. Legislative proposals currently being considered by the European Parliament and Council are expected to bring further responsibilities to the Agency.” 

As part of the agency’s new visual, or public, identity, the EMEA will launch a new website in the coming months. The site is expected to be easier for the public to use and designed to meet readers’ needs. 

Going forth, the agency will now be known as the EMA as opposed to the EMEA.

The EMEA unveiled several changes to the organization, including a new structure and visual identity.

EMEA restructures

The European Medicines Agency (EMEA) unveiled several changes to the organization on Dec. 8, 2009, including a new structure and visual identity, according to an agency press 

.
 
One primary structural change involves integrating human pre- and postauthorization activities into one unit “to guarantee seamless lifecycle-management of medicines,” says the release. Also, a group will be dedicated to the management of product data and documentation to help improve the efficiency of data-management processes throughout the agency.
 
This is the second time EMEA has undergone restructuring. Since its establishment in 1995, the agency’s “responsibilities and tasks have grown, giving it a stronger role in the protection of public and animal health in Europe,” according to the release. “All of this has been underpinned by the creation of additional scientific committees and advisory groups, which bring with them the need for enhanced coordination and support. Legislative proposals currently being considered by the European Parliament and Council are expected to bring further responsibilities to the Agency.”
 
As part of the agency’s new visual, or public, identity, EMEA will launch a new website in the coming months. The site is expected to be easier for the public to use and designed to meet readers’ needs. Also of note, from now on, EMEA will be known as EMA. 
 
 

 

The European Medicines Agency unveiled several changes to the organization, including a new structure and visual identity.

EMEA Restructures

 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, the ICH has benefited regulatory authorities.

In late October, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri (USA). As already 

, a major success of the meeting was the adoption of several annexes to the Q4B guideline on pharmacopeial texts.  

 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 programmes at the FDA's Center for Drug Evaluation and Research. She represents the FDA in the ICH's Global Cooperation Group (GCG) and in the 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." The conference can truly focus on implementation rather than talking around the table, she adds. 

In addition, ICH guidelines carry a lot of weight because regulatory bodies in the US, EU and Japan place approved (Step 5) guidelines in their own regulatory publications such as the 

. In fact, in the EU and Japan, ICH guidelines are mandatory. With the FDA and the US specifically, it's beneficial to industry that Step-5 ICH documents are published as guidelines rather than as regulations. "This allows industry to provide feedback and suggestions and to incorporate changes should better science be found," explains Molzon. "If we were to [incorporate these documents] in the regulations, we couldn’t change them. 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." 

Beyond the six-party system, 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, Labour and welfare; the Japan Pharmaceutical Manfuacturers Association, the 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 a Global Cooperation Group (GCG) 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.

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, the ICH has benefited regulatory authorities.