Pharmacopeias Continue Harmonization Program
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
On June 21, 2016, the European Directorate for the Quality of Medicines & HealthCare (EDQM) released
highlightsfrom the May 25â26, 2016 meeting of the Pharmacopoeial Discussion Group (PDG). The PDG signed off on one new monograph, Hydroxyethylcellulose, and two revised monographs, Ethylcellulose and Cellulose acetate.
The PDG, which includes the European Pharmacopoeia(EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia, discussed a number of outstanding issues and continues to focus its efforts on the elaboration of chapters related to chromatography and elemental impurities. The PDG aims to present a stage four draft of the new “Chromatography” chapter for public comment in the “near future.” The group exchanged information on their approaches to implementing the ICH guideline on elemental impurities and intends to continue harmonizing the chapter on testing procedures.
Harmonization of several other topics includes the following:
- Metal impurities. The stage three text is to be revised based on a teleconference held in February 2016.
- Inhalation. A teleconference will be held to discuss mass balance, interstage drug losses, and fine particle dose.
- Peptide mapping. The EP and JP will review the revised stage four draft.
- Calcium phosphate dibasic anhydrous. The group decided to republish the monograph for public comment with revised assay limits.
- Carmellose sodium. Some comments that have been received on the revised stage three draft still need to be addressed. The PDG is performing method development and validation on infrared identification.
Additional monographs discussed included lactose anhydrous/lactose monohydrate/lactose for inhalation, petrolatum, polyethylene glycol, polysorbate 80, silicon dioxide, stearic acid, talc, glycerin, and starch.
Five new items were also added to the PDG’s program: isostearyl alcohol, myristyl myristate, polysorbate 65, sodium cetyl sulfate, and calcium silicate. These additions increase the number of excipients to be revised to 67.
Source:
EDQM
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
