New EMA guidelines on good pharmacovigilance practices for biologics went into effect Tuesday. The guidelines – which apply to new biologics, biosimilars and other follow-ons – provide guidance on how to better monitor and manage the safety of biologics. The document advises on how to address specific challenges in pharmacovigilance for biologics and outlines the roles and responsibilities of the drug company and the various regulators.

The FDA revised its 2013 guidance on the classification of co-crystals for small-molecule drugs in an effort to encourage the development of the crystals, which can expand opportunities for engineering solid-state forms of APIs. Composed of two or more different molecules in the same crystal lattice, co-crystals can be tailored to enhance drug product bioavailability and stability, as well as the processability of APIs. The 2013 guidance classified co-crystals as a "drug product intermediate," creating uncertainty about the good manufacturing practices that applied to their production, according to an FDA notice slated for publication in Wednesday's Federal Register. Responding to stakeholder concerns, the FDA reconsidered the classification. The new draft guidance discusses the appropriate classification of co-crystal solid-state forms, the data needed to support the classification and the regulatory implications. Comments on the draft are due by Oct. 16.

The FDA this week rolled out its first major revision of its web-based version of the Orange Book, a database of approved small-molecule drugs and their therapeutic equivalence evaluations. The new look features an updated design with user-friendly search options. First published online in 1997, the Orange Book includes information about patents and exclusivity for the listed drugs and is one of the most searched-for features on the FDA's website.

German regulators advised other EU regulators to prohibit the entry of simvastatin API made at an Artemis Biotech facility in Hyderabad, India. The recommendation followed an inspection in which a German team noted 35 observations, including five major deficiencies that could potentially lead to a risk to human and veterinary patients. Most of the major deficiencies had to do with quality assurance (QA) issues. For instance, repackaging operations were conducted without any documentation and QA approval, inadequate controls were noted in the issuance of labels for raw materials and APIs, and the plant's instrumental laboratory violated basic principles on data integrity, according to a statement of noncompliance. While the inspection team didn't recommend an immediate recall of batches already imported, it advised a complete retest of all the batches. Artemis is a division of Themis Medicare Ltd., of Mumbai.

The FDA reported Tuesday that it placed Laxachem Organics Pvt. Ltd., of Maharashtra, India, on import alert for refusing to allow FDA investigators to inspect its facility. The company manufactures APIs for repackagers, labelers and wholesale drug distributors. Laxachem will remain on import alert until it has been inspected by the FDA and found to meet U.S. standards. In the meantime, U.S. companies that have received an API from Laxachem are not to distribute it or products containing it, the FDA said.

Noven Pharmaceuticals Inc., of Miami, received an FDA warning letter citing several manufacturing problems involving its transdermal drug delivery systems such as Minivelle and Daytrana. The Aug. 5 warning letter, posted Tuesday, is based on an FDA inspection conducted more than a year ago. The investigator claimed the company's scientifically unsound testing methods could be masking product failures, noting that the complaint rate for Minivelle had increased by 50 percent from fiscal 2013 to fiscal 2014. However, Noven failed to determine why complaints had increased. The inspector also observed calibration issues with the adhesive testing machine and undocumented deviations from required laboratory control mechanisms, according to the letter. In addition, the inspection revealed repeat problems, including the handling of complaints and failure to thoroughly investigate discrepancies in components or batches.