Regulatory/GMP Compliance, Emerging Markets

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

This article provides an overview on important aspects related to bracketing strategies in Japan.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

The Australian pharmaceutical market offers opportunities for manufacturers despite challenges.

The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.

The authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.

Is there potential for growth in Brazil's phytotherapic drug market?

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Brunei harnesses its rich biodiversity and the growing halal market in a bid to develop its pharmaceutical sector.

Biopharma companies should not overlook India's growing market.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R'D, clinical research, and market growth.

New regulation offers patients in Brazil greater access to experimental drugs.

The pharmaceutical industry grows despite conflict in the Middle East.

Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.

A unique demographic and payer mix make ASEAN an increasingly attractive region.

The authors present solutions based on a review of current service offerings and their audit experience.

An introduction to a new series on manufacturing within global markets.

Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told BioPharm International.