Other Regulatory Matters

Overview of GxP Data Integrity Guidelines

Daniel Price

This article outlines some key concepts of data integrity and describes some risk-based controls that can be used support data integrity.

Indonesia's Pharmaceutical News【October 2016】

Sundoro Iswanto

Dengue Hemorrhagic Fever (DHF) is an endemic viral infectious disease in Indonesia. The vectors are mosquitoes (Aedes aegypti and Aedes albopictus). These vectors usually bite for blood between 09.00 a.m. – 16.00 p.m. When it bites an infected person and then a healthy person, it transfers the virus to infect the latter.

Indonesia's Pharmaceutical News【August 2016】

Sundoro Iswanto

Indonesia’s economy was expected to grow by 5.5% this 2016 fiscal year when it was first published. However, it is reduced to 5.2% just a few weeks ago. The reasons are various but the most important factor is the price of some exporting commodities, mineral oils, etc. that makes the government income from taxes and the like is lower than planned.

The Present Situation and Trend of China's Regulation on Drug Registration

Keliang Zhang

Drug registration regulating refers to activities to regulate the evaluation and approval of new drugs, imported drugs and generic drugs according to relevant law. It is the first step of regulation drug by law, and critical measure to ensure the safety and efficacy of drug, and also an important part of drug administration.

【Part 4】Regulatory Issues in ASEAN countries and Business Trends

Factorytalk

For our 4th article on the ASEAN regulated healthcare industries we look to the requirements and progress in the area of Information Technology and Computer Systems Validation (CSV).

【Part 3】Regulatory Issues in ASEAN countries and Business Trends

Factorytalk

Multinational Players in the ASEAN Pharmaceutical Industry 3nd Article (submitted beginning of December):

【Part 2】Regulatory Issues in ASEAN countries and Business Trends

Factorytalk

Regional players in the ASEAN pharmaceutical industry. Regulatory and compliance challenges for local and regional manufactures in the region. 2nd Article (submitted September)

【Part 1】Regulatory Issues in ASEAN countries and Business Trends

Factorytalk

This article provides an introduction to the Association of South East Asian Nations (ASEAN)

Measures for Administration of Oversea Pharmaceutical Manufacturing Enterprise Inspection (China)

GMP Platform

Measures for Administration of Oversea Pharmaceutical Manufacturing Enterprise Inspection (China) In order to regulate the inspection of the oversea pharmaceutical manufacturing enterprise, this measure is enacted according to 'Drug Administration Law of the People's Republic of China','Regulations for Implementation of the Drug Administration Law of the People's Republic of China', '　　The State Council's Special provisions on strengthening the supervision and administration of food and product safety' and other regulations.