The Medical Industry’s Move Toward Quality, Part Five

Speeding up the introduction of new medical devices and drugs

Previous articles in this series discussed how process management and risk-based initiatives are changing the Food and Drug Administration’s approach to medical device and pharmaceutical product reviews. We also examined the global movement toward process management and its subset, risk management, in medical device reviews and approvals. Last month we looked at how ISO 13485:2003 points the way toward globalization of the medical device industry and, by extension, the pharmaceutical industry.

This article will review some of the ways the FDA and various international groups have been working toward harmonizing regulatory processes.

To reduce premarket review times and overall development spans for new medical technology, the FDA must make greater use of outside resources, focus on breakthrough technologies and accelerate the review process without sacrificing safety or performance. To facilitate these goals, Congress passed the Medical Device User Fee and Modernization Act, which became law on Oct. 26, 2002. The MDUFMA authorizes the FDA to charge a fee for medical device product reviews. In addition, the law allows for establishment inspections by accredited persons (i.e., third parties) and creates new regulatory requirements for reprocessed single-use devices.

The United States is the world’s largest producer of medical technology and a major contributor to improved patient care internationally. However, foreign governments’ approval requirements are sometimes unclear or slow, delaying patient access to innovative technology. Nations around the world are now working together to ensure that they support timely patient access to advanced medical technology.

Conversely, to protect the health of U.S. consumers, the FDA doesn’t limit its activities to the United States. FDA-regulated products manufactured in other countries must meet the same standards as those produced domestically. Thus, the FDA’s international activities encompass:

Pharmaceuticals

Medical devices

Biologics

Food

Cosmetics

Animal drugs and feed

Radiation-emitting products

To help simplify the regulatory processes for medical devices and pharmaceuticals, the FDA is cooperating in two international initiatives: the Global Harmonization Task Force for medical devices and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use--or ICH.

The GHTF was organized in 1992 in response to the growing need for international harmonization in regulating medical devices. The five founding members are the United States, the European Union, Canada, Australia and Japan. The GHTF is a voluntary group of representatives from authorities in national medical device regulatory agencies and the medical device industry. Since its inception, the GHTF has comprised representatives grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using its own regulatory framework.

The GHTF’s goals include encouraging harmonization of regulatory practices related to the safety, effectiveness, performance and quality of medical devices. By publishing guidance documents on basic regulatory practices, it also seeks to promote technological innovation and international trade. These documents can then be adopted and implemented by member national regulatory authorities. The GHTF also serves as an information exchange forum, so that countries with developing medical device regulatory systems can benefit from the experience of those with existing systems.

The ICH brings together government regulators and drug industry representatives from the United States, the European Union and Japan to coordinate a more efficient and uniform international drug regulatory procedure. The objective is to make new drugs available with minimum delays to the people who need them.

The drug regulatory systems in all three regions share the same fundamental concerns for a new drug’s safety, efficacy and quality. However, time-consuming and expensive clinical trials are often repeated in all three regions. An ICH goal is to minimize unnecessary duplicate testing during the research and development of new drugs. Another goal is to develop guidance documents that create consistency in the requirements for new drug approval.

Guidance documents represent current thinking on a particular subject, specifically the processing, content, evaluation and approval of applications. They also establish policies intended to achieve consistency in each member’s regulatory approach and establish inspection and enforcement procedures. Guidance documents aren’t regulations or laws, and thus aren’t enforceable, either through administrative actions or court procedures.

ICH guidance documents are developed through a five-step process:

1. Consensus building

2. Creating regulatory action

3. Regulatory consultation

4. Adopting text

5. Implementing regulation

When a guidance document reaches steps two or four, the FDA publishes a notice of availability in the Federal Register. Guidance documents are posted on the Internet and placed on the docket for viewing and public comment.

For regulatory purposes, the European Commission recognizes ISO 13485:2003 as a “harmonized” standard for medical device manufacturing quality management systems under the three European medical device directives: Medical Device Directive, Active Implantable Medical Device Directive and In Vitro Diagnostics Directive. This action means that compliance with ISO 13485:2003 may now be used to demonstrate that the quality assurance requirements for CE marking of medical devices have been met.

Despite these initiatives, actual regulatory implementation is proceeding slowly. Obviously, where public health and safety are involved, governments are hesitant to take shortcuts. Moreover, the number of new drugs and devices being introduced is increasing almost exponentially, straining the already overtaxed resources of the regulatory bodies. In future articles, we’ll examine some specific activities leading to improved regulatory procedures.

About the author

Stanley A. Marash, Ph.D., is chairman and CEO of The SAM Group, which includes STAT-A-MATRIX Inc. and Oriel Inc.