The European Medicines Agency has finalised a review into the supply chain for protamine-containing medicinal products.


The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that protamine sulphate sourced from the Hokkaido Island fishing areas off the coast of Japan does not differ significantly from historical batches of the product derived from the traditional fishing grounds off Japan’s Honshu Island.


The Committee therefore recommends that protamine sulphate sourced from the Hokkaido fishing grounds can be used for the manufacture of medicinal products both as an active substance and as excipient. As a result, there will be no supply shortage for medicinal products containing protamine in the European Union (EU).


The CHMP also noted that it is important for marketing-authorisation holders of medicinal products containing protamine to investigate alternative authorised suppliers of protamine to better manage any future supply issues.


Background information


Protamine sulphate is a purified mixture of simple proteins obtained from the sperm or roe of wild salmon traditionally fished off the north-east coast of Honshu Island. It is used to counteract the anticoagulant action of heparin in the treatment of bleeding resulting from heparin overdose. It is also used to neutralise the effect of heparin, particularly in cardiac surgery. Protamine in this indication is marketed in many EU countries. It is also used as an excipient in insulin-containing products and some vaccines. The main distributor of protamine sulphate as active substance in the EU is a Japanese firm.


Following the earthquake and tsunami in March 2011, the Japanese fishing industry was no longer able to operate in Honshu fishing grounds due to a shortage of boats and a lack of shore-support services. In order to maintain a supply of protamine, the fishing grounds for the wild salmon were moved north to Hokkaido Island.


This change in the source of the raw material led to differences in the active substance. Following the assessment of all available data, the CHMP concluded that these differences have no impact on the quality of the medicine.


Posted on the EMA wesbite on 16 November 2012