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近日,本刊记者从卫生部获悉,自今年7月1日起,我国不再受理未通过GMP认证的企业申请新药生产。此规定旨在加快推进实施GMP制度的进程,促进生产企业技术改造的发展。 此前,我国分别于1995年和1997年对实施GMP采取了一定措施,并就新药申报提出了具体要求。为保证新药审批工作的正常运行,卫生部就近期新药申报做出了新规定:自1998年7月1日起,对未取得GMP认证证书的企业,卫生部不予受理生产新药的申请,在批准新药后,只发给新药证书,而不发给药品标准文号;在
Recently, our reporter learned from the Ministry of Health, since July 1 this year, our country will no longer accept companies that have not passed GMP certification to apply for new drug production. This provision aims to accelerate the process of implementing the GMP system to promote the technological transformation of manufacturing enterprises. Earlier, China took certain measures to implement GMP in 1995 and 1997, respectively, and set forth specific requirements for the declaration of new drugs. In order to ensure the normal operation of drug approval, the Ministry of Health has made new provisions on the recent declaration of new drugs: Since July 1, 1998, the Ministry of Health will not accept applications for the production of new drugs for enterprises that have not obtained the GMP certificate. After the approval of a new drug, only a new drug certificate is issued, but the drug standard number is not issued