Domestic pharmaceutical equipment new GMP medicine enterprises disconnected from the pressure of sha
While the State Food and Drug Administration issued on pharmaceutical production enterprise implementation of the guidance of the new amendment of GMP of thorough investigation do work, "which called the world reported thoroughly the situation, pharmaceutical equipment problems began to emerge.
Chinese Journal of Chemistry (Quotes, information) Pharmaceutical Industry Association has released two sessions on behalf of members under the proposal (material) (known as the "quasi-proposal") specifically details the new GMP problems and difficulties in the implementation process, and problem solving . This "quasi-proposal" not only appeal to the relevant ministries to proceed with the pharmaceutical equipment industry to speed up the butt the new GMP standards, and also suggested that the relevant departments to establish long-term mechanism to give corporate compensation, from the aspects of tendering and pricing in order to accelerate the new version of the domestic pharmaceutical companies GMP transformation.
Imported equipment is 5-10 times more expensive than domestic
According to industry experts, pharmaceutical companies during the new version of the GMP process, the use of domestic equipment or imported equipment, the decision more with less capital investment. At present, the price of imported equipment generally about the price of domestically produced equipment 5 to 10 times. The current relatively low prices of essential drugs, if the companies do not use domestic equipment production, the cost is approximately doubled.
China Pharmaceutical Industry Association
Some experts, China's pharmaceutical and equipment manufacturers are usually from drug manufacturers to understand the GMP requirements and show little interest in GMP, pharmaceutical equipment design department, the existence of the problem, partly the result of a domestic pharmaceutical equipment is difficult to reach a new version of the GMP requirements.
The association is therefore recommended that regulatory bodies or trade associations of the pharmaceutical equipment as soon as possible to establish a match with the new GMP qualified pharmaceutical equipment market access system, accelerate the pace of the domestic pharmaceutical equipment enterprise product upgrading, so that the pharmaceutical companies in the new GMP able to use domestic equipment to meet the new GMP requirements.
However, Cheng-Dong Wang, general manager of the East medicine machine in an interview with the Southern Reporter, deny that the domestic pharmaceutical equipment and docking of the new GMP. In his view, made an oral preparation production equipment, has been widely used.
It seems the Chipscreen President Lu Xianping, "Pharmaceutical Industry Association, the problems mentioned for the injectable formulation, oral formulation, domestic equipment was able to meet the new GMP requirements." He said, domestic equipment So in some indicators did not meet the new GMP requirements in traceability, risk control, did not keep pace with international standards.
Industry to look forward to a long-term compensation mechanism
According to data provided by North China Pharmaceutical (Quotes, information) to the Pharmaceutical Industry Association, the new GMP implementation process, the transformation of the input.
"According to incomplete statistics, only the North China Pharmaceutical AG (does not contain the old plant of the other subsidiaries) to complete a full GMP, expected to cost 200 million yuan, discontinued to transform the impact of sales revenue of 500 million yuan, and the whole North Pharmaceutical Group, the company modified the amount of investment will be greater, more sales of discontinued due to the transformation. "the aforementioned quasi-proposal case statements.
In addition, a generally accepted view is that the implementation of the new GMP is bound to a certain extent, increase the operating costs of enterprises. On behalf of members to powder for injection, for example, said "Due to the reasons of production efficiency and power costs, production costs will increase the more than 30%.
In this context, one to hope that the prospective proposals to national authorities issued a long-term compensation mechanism forming.
"Our proposal is to adjust the national drug tender procurement and drug pricing policies such as: the enterprise has passed a new version of the GMP, when the bidding and purchasing of essential drugs, bonus points, a separate quality levels in the non-essential drugs in the bidding, so that according to the new version of successful rate of GMP-compliant production of drugs may be raised; follow the principle of 'competitive prices', the differential pricing of its priority to be given the above quasi-proposal that.
CPPCC National Committee members, Cologne Pharmaceutical (market information) chairman Liu innovation is called for shortening the process of transition to the new GMP pharmaceutical industry from the old version of GMP, the end of two quality system parallel to the unfair competitive situation as soon as possible, reflecting the differential pricing.
In his view, the products produced under the two different quality operation system, it is in the price, the cost of inputs is certainly not a level due to the low standard of the earlier versions of the GMP in 1998, with a very low cost to destroy the industry average cost, in this circumstances could lead to a large number of competitive enterprises of the mainstream business enterprises to adhere to the new GMP standards out. Should therefore reflect the differences in pricing, there must be a factor.
