Newsletter : International Regulatory Principles & Practices in The Pharmaceutical Industry

Featured Articles:

Highlights:

News:

Events:

5th International Specialized Pharmaceutical Exhibition, PharmExpo Uzbekistan 2009
Achievement Of Public Health Services Of Turkmenistan Renaissance 2009
SRS Pharmaceuticals Pvt. Ltd., Successfully Exhibits At The International Exhibition And Scientific Conference, Held At Ashgabat.
SRS To Exhibit In The Upcoming CPhI- India 2009

EDITORIAL FROM REGULATORY DEPARTMENT

PRODUCT REGISTRATION AS PER ACTD GUIDELINES - A REGULATORY STEP-UP

Aug. 2009

With the globalization, increased harmonization vigilance, introduction of new technologies and advance of science, the pharmaceutical industry is now adapting new and good international regulatory principles & practices in order to foster strategic partnerships globally and achieve global expansion.

In order to keep up with the ever increasing and developing pharmaceutical industry, SRS Pharmaceuticals Pvt. Ltd., India, has started product registration in ASEAN countries as per the ACTD Format, initially for Injections. The work is under progress on the ACTDs with the key focus areas being Validations, Clinical Trials and BE Studies.

ASEAN common technical dossier (ACTD) is a guideline agreed upon common format of the preparation of well structure common technical dossier (CTD) application that will be submitted to ASEAN regulatory authorities for the registration of the pharmaceuticals for human use. A Common Technical Dossier (CTD) is divided into 4 modules namely:

Table of contents, Administrative and product information - contains a general introduction to the pharmaceutical, including its pharmacological class and mode of action should be included.

Quality Document - containing overall summary followed by study report.

Nonclinical Document - containing Nonclinical overview, followed by the Nonclinical written summaries and the Nonclinical tabulated summaries.

Clinical Document - containing clinical overview and clinical summary.

Throughout the ACTD the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application content.
ACTD Guidelines demonstrates an appropriate write-up format for the acquired data of a product and is a milestone step up in the process of global expansion of SRS Pharmaceuticals Pvt. Ltd.

Ref: www.has.gov.sg

top

TOP