Second, improvement of drug development requires more transparency from the regulatory bodies.

China s decision to execute the head of its drug regulatory agency has rekindled international debate about capital punishment.

Above all, the success of any comprehensive effort to improve drug safety hinges upon establishing an independent office of drug safety to advocate, coordinate, and provide direction to the regulatory agenda.

Physicians may feel guilty and fear litigation, drug companies worry about the threat to corporate profits and regulatory agencies must face the question Why was the drug approved in the first place?

Proper and complete documentation of harmful drug effects is difficult. Spontaneous reporting rates to regulatory agencies are low approximately 1 and ongoing monitoring is passive in many countries.

Such barriers are particularly pronounced in the US, where Congress oversees the legal framework within which federal regulatory agencies such as the Environmental Protection Agency and the Food and Drug Administration operate.

Regulatory issues

Regulatory action

Absent international coordination, the opportunities for destructive regulatory competition will defeat regulatory reform.

Other regulatory controls

Legal and regulatory environment3

In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.

The Harm of Regulatory Disharmony

Regulatory philosophies are converging, too.

Franchising poses particular regulatory challenges.

At the same time, governments will have to implement policies aimed at guiding investment toward specific diseases. For example, increased NIH funding, extended market exclusivity, and relaxed regulatory hurdles in the US resulted in a renaissance in antibiotic drug development.

But there are indications that the process is being driven by regulatory change, and in some cases by regulatory protectionism.

A Regulatory Impact Analysis or Regulatory Impact Assessment (RIA) is a document created before a new government regulation is introduced.

In the sixth preambular paragraph, the words national and legal regulatory infrastructure should be replaced by national, legal and regulatory infrastructure .

Other big legal and regulatory costs loom.

Policy, Regulatory Frameworks and Equitable Benefit Sharing

The Office will continue to support implementation of the international drug control treaties by providing scientific advice and expertise also to national regulatory and competent authorities, the Commission on Narcotic Drugs, the International Narcotics Control Board and other relevant regional and international bodies.

(a) In the sixth preambular paragraph, the words national and legal regulatory infrastructure were replaced by the words national legal and regulatory infrastructure

International drug control

Intravenous drug users

Drug demand reduction

Drug demand reduction

International drug control

Female drug addicts

International drug control.

That is how regulatory progress is often made.

Regulatory encouragement may be helpful, perhaps even necessary.

Financial innovation will proceed along with regulatory arbitrage.

Discussion must start by agreeing on regulatory principles .

Emphasizing the primary importance of international cooperation in combating drug trafficking and drug abuse,

It must be recognized that regulatory reform entails adjustment costs and necessitates regulatory capacity and institution building, technical assistance and capacity building in this regard.

And Tamiflu. You've probably heard of this drug, made by Hoffmann La Roche, patented drug.

National drug control strategies

Afghanistan s Drug Friendly Environment

Burma s Drug Lord Generals

Our Other Drug Problem

Taking Drug Safety Seriously

The world drug problem

National drug control strategies

National Drug Monitor 2003.