It is the first approval by a regulatory body of a cancer immunotherapy.

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

But the overall approval process was more capricious than scientific.

Along this path, many potential drugs are withdrawn, and even successfully tested drugs face the additional hurdle of regulatory approval.

Obtaining approval for the NAPA proposal continues to be a slow process.

More than half of all approved drugs produce a serious adverse reaction that is not known at the time of regulatory approval.

However, national approval procedures in both countries needed to be completed and, in Germany, this involved the application for a plan approval process.

But, after more than three decades of active research and development, no clinically viable product has obtained regulatory approval, owing to the significant scientific challenges.

As such, they should not be subject to the same approval process as normal legislation.

But this implies a complex and cumbersome approval process and the provision of high quality collateral.

(b) Document management applications to support the project approval process of the Programme and Projects Committee

It proposes direct approval of a Charter amendment rather than a complex and uncertain three stage process.

Following Roosevelt's death in April 1945, the new president, Harry S. Truman, gave strong approval for a judicial process.

It carefully formulated its initial offer, including by going through an extensive stakeholder consultation process and through parliamentary approval.

As reported to the Board at its twenty ninth session, the programme and project approval process had been streamlined through the establishment of four project approval committees (PACs) (IDB.29 12, para. 10).

Notifications of final regulatory action from the parties are part of the unified process of making proposals to amend Annex III.

Conditions for gun ownership in Australia are now very strict, and the registration and approval process can take a year or more.

Requests the Secretary General to use his good offices to accelerate the process of approval for projects already identified for Sierra Leone.

Regulatory issues

Regulatory action

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

June 2008 The HyApproval project, FP6 N 019813 developed a universal handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe.

It was launched without the approval of the Cabinet or the Civil Aviation Authority and its three aircraft were leased without a tender process.

Following their approval by the relevant bodies in UNIDO and UNDP, they are now in the process of being approved by the Governments concerned.

Other regulatory controls

If this were simply a sign of a new, tighter focus on viable long term strategies, it might be regarded it as a benign development. But there are indications that the process is being driven by regulatory change, and in some cases by regulatory protectionism.

A partnership between governments, non profit research institutions, charities and pharmaceutical companies might be one way to clean up the approval process for new drugs.

Under the Environmental Assessment process, the Government can require that employment equity conditions be part of major projects that require the Government's approval to proceed.

Legal and regulatory environment3

Judith Rodin, the president of the Rockefeller Foundation, announced last October that her organization will provide funding to the International Rice Research Institute to shepherd Golden Rice through national regulatory approval processes in Bangladesh, India, Indonesia, and the Philippines.

Certification and approval

At present, a new drug s producer prepares the entire dossier presented to the regulatory authority for approval in the interests of the public, at least one of the clinical trials should be carried out by an independent non profit organization.

The rules vary among EU countries, but, in Germany, government approval implies parliamentary approval.

Recognizes the progress made in implementing Executive Board decision 2001 11 on the UNDP UNFPA programming process and therefore reconfirms the validity of the current approval procedure

IAEA is also assisting the nuclear regulatory authority of Ukraine in the regulatory process of decommissioning the Chernobyl nuclear power plant and in the development of an approach for characterizing and managing radioactive residual material resulting from investigating the status of the shelter and its reconstruction and or repair.

The Harm of Regulatory Disharmony

Regulatory philosophies are converging, too.

Franchising poses particular regulatory challenges.

After the endorsement by the Expert Group, the ISCO will go through an approval process involving an International Labour Organization tripartite meeting and the International Conference of Labour Statisticians.

A delegation requested the secretariat to continue consultations with the other Executive Committee agencies and to prepare common proposals for any changes in the approval process and further harmonization.

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

This is good news, but what is really needed is a multi faceted, aggressive reform of the regulatory process so that all new genetic constructions will have a chance to succeed.

Its successors are radically different in how they work, as is the regulatory framework, which sets astonishing new benchmarks for the care and quality required at every stage of the process.

Signature, ratification, acceptance, approval, accession

Ratification, acceptance, approval or accession