USAID and Jordanian Association of Pharmaceutical Manufacturers cooperate to ensure industry accreditation

A two days workshop that introduces Good Laboratory Practice (GLP) is scheduled to convene at Grand Hyatt Amman on 8 and 9 February 2009.

To export Jordanian pharmaceuticals, mainly branded generics, a prerequisite of their registration demands a bioequivalence study which proves generics' comparability with originators' products. The bioequivalence study is usually conducted at Contract Research Organizations (CRO) that apply Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).

This project aims to develop CRO systems to be in line with international GCP and GLP standards. Such standardization will first enhance opportunities for Jordanian pharmaceuticals expansion and their meeting regional and international demand, and second ensure internationally accreditation and recognition.

The Pharmaceutical sector in Jordan is an export driven industry, employing over 8,000 people and exporting approximately 70-80% of its production annually. In 2007 pharmaceutical exports amounted to a total of $430m, representing 7.7% of Jordan's total exports.

"Jordanian pharmaceutical products enjoy a very good reputation in Jordan and export markets, due to the high quality standards applied at the manufacturing facilities and at the (CROs) that conduct the bioequivalence studies. Five of the contract research organizations in Jordan, the pharmaceutical companies together with JFDA are participating in this workshop aiming to be fully compliant with international health authorities' requirements via applying the current good laboratory practices (cGLP)," said Hanan Sboul, Secretary General, JAPM.

The first day of the workshop is designed to inform participants from the pharmaceutical sector on principles of GLP and the process of restructuring laboratories to gain international qualification and validation. The second day will focus on the GLP plan, application, and how best to respond to GLP audits.

"It is our pleasure to work alongside JAPM to ensure Jordan is in the forefront of regional pharmaceutical exporters. We believe that the good work this vibrant sector is putting into the industry will ensure it finds its way into international markets,"

said Laith Al Qasem, Chief of Party, USAID Jordan Economic Development Program (SABEQ).

The USAID Jordan Economic Development Program (SABEQ) is a five year broad economic development initiative implemented by Bearing Point, Inc. and a sizeable team of international and Jordanian partner firms. By both supporting improvements in the business environment and providing assistance to expand innovation and productivity in Jordanian businesses, it supports the main objective of building up the private sector as a powerful engine of economic growth.