Last week’s round -up;
13 -17 September 2021

published 20 Sep 2021

New EMA Product-Specific Bioequivalence Guidance

The EMA has adopted the following new product-specific bioequivalence guidance, which come into effect on the 1st November 2021:

· Acenocoumarol, tablet, 1 mg and 4 mg

· Lapatinib film-coated tablet 250 mg

· Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg

FDA’s novel excipient pilot program opens for candidates

The FDA has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The Authority will accept four initial proposals in the pilot “but will consider accepting more proposals as resources allow.” The following criteria will be used to select candidates:

· The potential public health benefit of the novel excipients; for example, such applications as use in opioid abuse-deterrent formulations or to promote new therapies for serious and life-threatening disease.

· The likelihood of the novel excipient manufacturer’s ability to submit a complete package within the established timeframe.

· The potential of the novel excipient to “meaningfully improve pharmacokinetic characteristics” and lead to the development of novel drugs. Following acceptance of the initial proposals, the excipient manufacturers concerned will then be requested to submit a full toxicology package as well as chemistry, manufacturing, and controls data in a process parallel to that for an investigational new drug application. Proposals for novel excipients are being accepted until the 7th December 2021.

New Ph. Eur. general chapter on balances

The Ph. Eur. Commission has adopted a new general chapter Balances for analytical purposes (2.1.7), which has been published in Supplement 10.6 in July 2021. This new chapter fills a gap in section 2.1 Apparatus by setting out clear requirements for the use of analytical balances, as weighing is one of the most critical tasks carried out in the laboratory since even the smallest error will affect the accuracy of results. The chapter covers installation and use of analytical balances, including good practices for weighing vessels and provides detailed information on calibration and performance checks. These checks focus on two weighing parameters that most significantly affect balance performance, repeatability and sensitivity. The result of the repeatability test described in the text can also be used to calculate the minimum weight of the balance. The new chapter complements existing guidelines for the use and qualification of balances. It is supplemented by the instructions related to “Quantities” given in the recently revised General Notices chapter, which is due to be published in Supplement 10.7.


Search Real Regulatory