Pharma companies are used to having to work hard to keep regulators happy, so dealing with FDA inspections and keeping tabs on side-effects of marketed medicines ensure that regulatory affairs departments remain busy. But now there's something else they're going to have to worry about in Europe—new chemicals legislation.
The legislation—Registration, Evaluation and Authorization of Chemicals (Reach)—is at the second-reading stage in the European Parliament, having undergone significant amendments since it was first introduced. It is designed to replace a sprawling array of more than 40 different pieces of legislation; a final agreement by the European Parliament is expected in the fall of this year.
Around 30,000 existing substances will have to be registered within an 11-year phase-in period. How much data is required will depend on how much of each chemical is produced, and whether they are dangerous, such as carcinogens, mutagens, or bioaccumulative chemicals.
Dangerous materials will have to undergo an authorization process. Although medicinal products will likely be exempt from the legislation, chemicals are involved in the manufacturing of those products, so Reach will have an impact on pharma. The industry, through its primary manufacturing operations, makes and uses chemicals that will fall under the scope of Reach, and others are involved in the formulation stage. Many more are purchased from outside suppliers.
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