Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises the marketing authorization function as the National Regulatory Authority (NRA). This paper provides an overview of the organization, regulatory expectations and current practices of the […]
Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this […]
Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution. The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was signed into law on 23 March 2010 by President Barack Obama. The BPCI […]
Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterization of quality attributes, and clinical and non-clinical studies for biosimilars. In this paper, the requirements for regulatory approval of biosimilars in Japan are […]
Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. This paper introduces PMDA’s current situation (until spring 2012) including its organisational […]
Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists. The new regulations will provide a legal framework for patients to report adverse events […]
