Pan American Network for Drug Regulatory Harmonization (PANDRH)

DIRECTORY OF DRUG REGULATORY AUTHORITIES IN THE AMERICAS

Directory of Drugs Regulatory Authorities in the Americas

Pharmacological Standards
SPANISH ONLY

Subregional Meeting
August-2005
Regulatory Authorities of Central America, Cuba and Dominican Republic
SPANISH ONLY

PAHO/WHO Harmonization
Pharmaceutical Regulation Resolution

Documents that support the development of the Pan American Network for Drug Regulatory Harmonization are presented (PANDRH) here

PANDRH Norms And Regulations

This document describes the goals. objectives and the functions of the PANDRH components and the secretariat.

Decisions take by PANDRH’ Steering Committee presented in the documents of its meetings.

Full Text

Report from the Secretariat 1997 - 2005

Steering Committee

Panamerican Conference on Drug Regulatory Harmonization

These conferences constitute a continental forum that deals with the drug regulatory harmonization. It includes the presence of all the region’s drug regulatory authorities, as well as representation of organisms for economic integration such as CARICOM, MERCOSUR, TLCA, Latin American Association for Integration (ALADI) and the Andean Community; Academics; representation of regional professional association; and other groups interested from all the continent sub-regions.

The conference constitutes a way to disseminate the decisions on drug regulatory harmonization of global initiatives, such as the International Conference of Drug Regulatory Authorities (ICDRA) and the International Conference on Harmonization (ICH). The PANDRG has become member of the Global Cooperation Group of the ICH www.ICH.org

The Conference also facilitates the integration of the countries from the continent that do not belong to the sub-region blocks, as is the case of Cuba, Dominican Republic and Chile. Its main objective is to support the harmonization processes through the analysis of specific aspect and the adoption of recommendations on priority subjects and harmonized guidelines proposed by the working groups established by the conference itself. Conclusion and recommendations Conference are expected to used by the economic integration groups in its harmonization processes and by all drug regulatory authorities in the countries of the region.

PANDRH TECHNICAL WORKING GROUPS

They are groups of experts in areas that have been identified as priorities for the drug regulatory harmonization. Members are selected by the Steering Committee and confirmed by the regulatory authorities of the respective countries. Whenever possible, WG should have at least one representative for each of the five sub-regional blocs of the Americas.

Academics and other experts can be members of the WG. Its main objectives include the implementation of diagnostic studies in order to identify the differences among the countries regarding the implementation of internationals standards and to define the necessary strategies for technical cooperation; analyze international guidelines and prepare harmonized proposal in their areas to be considered for the conference for its implementation in the region.
PANDRH rules and regulations have a specific chapter on WG operation.

Good Manufacturing Practices : Bioequivalence : Good Clinical Practices :
Combat to Drug Counterfeiting : Pharmacopoeia : Drug Clasification:
Medical Plants : Pharmaco Vigilance: Drug Registration :
Drug Promotion: Good Laboratory Practices : Vaccines Only Spanish

RELATED DOCUMENTS

	Pre Conference REDPARF
	Drug Regulation Agencies