Importing from China may involve some risk. In Great Britain, in fact, the Ministry of Commerce and Industry has pointed out that reports to the European Union, through the Rapid Alert System for Non-Food Products, have increased to 58 for products of Chinese origin against 16 relating to products of European origin. In general, still in Great Britain, withdrawals of products from the market increased by 8% in 2006, again due to the growing imports from the Far East.
It is obvious that all possible types of products are involved, from the needle to the spaceship, but an article in Inpharmatechnologist warns against neglecting this aspect when it comes to the pharmaceutical sector, given that both the United States and the European Union Europe have both complained of a lack of attention from their respective regulatory bodies towards foreign producers of pharmaceutical raw materials. Moreover, the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) have for some time been pressing for increased inspections of production plants by companies exporting to the US and European markets. In short, it would be a question of giving effect to the regulations on Good Manufacturing Practice which exist and are in turn quite stringent. According to EFCG and SOCMA, 75-80% of all pharmaceutical raw materials used in Europe and the United States are imported, mainly from China and India, although many of the source industries have not been inspected. In truth, there is one certain figure, it concerns the United States and dates back to 1999, however, the year in which the FDA itself published a report according to which 242 companies that exported to the country had not undergone any checks. The situation in Europe would not be much better, where the Union is unable, the two associations always maintain, to provide the number of companies that export to its territory, regardless of whether or not they have been subject to inspections.
It is obvious that all possible types of products are involved, from the needle to the spaceship, but an article in Inpharmatechnologist warns against neglecting this aspect when it comes to the pharmaceutical sector, given that both the United States and the European Union Europe have both complained of a lack of attention from their respective regulatory bodies towards foreign producers of pharmaceutical raw materials. Moreover, the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG) have for some time been pressing for increased inspections of production plants by companies exporting to the US and European markets. In short, it would be a question of giving effect to the regulations on Good Manufacturing Practice which exist and are in turn quite stringent. According to EFCG and SOCMA, 75-80% of all pharmaceutical raw materials used in Europe and the United States are imported, mainly from China and India, although many of the source industries have not been inspected. In truth, there is one certain figure, it concerns the United States and dates back to 1999, however, the year in which the FDA itself published a report according to which 242 companies that exported to the country had not undergone any checks. The situation in Europe would not be much better, where the Union is unable, the two associations always maintain, to provide the number of companies that export to its territory, regardless of whether or not they have been subject to inspections.
However, the situation is evolving, at least in the Old Continent, given that a written Declaration dates back to the end of last year on the question of active ingredients and pharmaceutical raw materials which commits the Commission, ultimately the real legislative body, to take note of the addresses expressed. The declaration states that producers and importers of active ingredients must provide a Certificate of Good Manufacturing Practices (GMP) which, in the case of importers, can no longer be that of the country of production but must be issued by European authorities following inspections mandatory. Another fundamental point is the provision of a traceability system for the active ingredient, similar to what occurs for food and textiles, which involves the inclusion in the label of the country, company and production plant of the molecule. The aim, says the declaration verbatim, is to discourage the re-labelling/re-packaging of products of non-EU origin.
From Swabian Prati "www.pharmamarketing.it"
From Swabian Prati "www.pharmamarketing.it"
