Guidelines

Japanese guidelines for generics

Last update: 1 July 2011

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs [1].

US biosimilars pathway unlikely to be used

Healthcare reform in the US was brought into force by the Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act) and was signed into law on 23 March 2010 by President Barack Obama.

Regulatory recommendations for biosimilars in the EU

The regulatory body for approval of medicines in the EU is the EMA.

The EU has developed a general legal pathway, and the EMA has developed regulatory guidelines, for the approval of biosimilars (see below).

Saudi Arabian guidelines for biosimilars

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade, and registration in Saudi Arabia.

Saudi Arabian guidelines for generics

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade and registration in Saudi Arabia.

FDA to release guidance on generic tablet size

The FDA hopes to release guidance in the next few months to help generic drug makers understand how big or small their tablet or capsule can be compared to the branded equivalent, an agency official said.

FDA issues new bioequivalence guidance for generics

In May 2011, the FDA issued new guidance for the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). This new guidance means that all bioequivalence data will now have to be submitted, including failed studies.

EMA, FDA and TGA joint GMP inspection programme

On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities.

FDA and EMA to join forces on quality

EMA and FDA have launched on 1 April 2011 a three-year pilot programme to allow parallel evaluation of quality elements, known as Quality by Design (QbD), of selected applications submitted to both agencies at the same time.

China’s regulatory authority adopt CTD format for NDAs

On 25 September 2010, China’s State Food and Drug Administration (SFDA) issued new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.