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1. 新修订《药品管理法》通过
2019年8月26日，新修订的《中华人民共和国药品管理法》经十三届全国人大常委会第十二次会议表决通过，将于2019年12月1日起施行。
新法鼓励研发创新，保障药品可及。重点支持以临床价值为导向，对人体疾病具有明确疗效的药物创新，鼓励具有新的治疗机理，治疗严重危及生命的疾病、罕见病的新药和儿童用药的研制。
新法明确，进口未批新药不再算假药，常规处方药可在网上购买。此外，新修订的《药品管理法》规定，国家建立药品追溯制度。上市许可持有人、生产经营企业、医疗机构要建立实施药品追溯制度，各个单位自建追溯体系，要做到数据互联互通。
1. Newly Revised Pharmaceutical Administration Law Adopted
On August 26, 2019, the 12th Session of the Standing Committee of the Thirteenth National People's Congress voted and passed the newly revised Pharmaceutical Administration Law, which should come into force on December 1, 2019.
The new law encourages research, development and innovation to ensure the accessibility of pharmaceuticals. Priority to the innovation in pharmaceuticals with clear curative effects on human diseases based on the clinical value is given, and the research and development of new pharmaceuticals with new therapeutic mechanisms used to treat seriously life-threatening diseases and rare diseases, and pediatric pharmaceuticals are encouraged.
According to the new law, imported unapproved new pharmaceuticals no longer count as counterfeit medicines, and regular prescription pharmaceuticals can be purchased online. In addition, the state establishes a pharmaceutical traceability system, under which pharmaceutical marketing licenses holders, production and trading enterprises, and medical institutions are required to implement their pharmaceutical traceability systems independently established so as to achieve data interconnection.
2. 《中华人民共和国资源税法》发布
2019年8月26日，经十三届全国人大常委会第十二次会议表决，资源税法正式通过，将于2020年9月1日正式实施。
资源税法带来的变化体现在三点：一是简并了征收期限。新税法规定由纳税人选择按月或按季申报缴纳，并将申报期限由10日内改为15日内，与其他税种保持一致，切实减轻办税负担。二是规范了税目税率。新税法以正列举的方式统一规范了税目，分类确定了税率，为简化纳税申报提供了制度基础。三是强化了部门协同。新税法明确规定，税务机关与自然资源等相关部门应当建立工作配合机制，以减少争议，维护纳税人合法权益。
2. Resource Tax Law Issued
On August 26, 2019, the Resource Tax Law of the People's Republic of China was adopted at the 12th Session of the Standing Committee of the Thirteenth National People's Congress, and will come into force on September 1, 2020.
The main changes are appreciated in the Resource Tax Law as below: Firstly, simplifying and combining the time limit for tax collection. Taxpayers may choose either on a monthly or quarterly basis to file tax returns, and the declaration period is extended from 10 days to 15 days in line with that for other tax types so as to effectively reduce the tax service-related burden. Secondly, regulating the taxable items and tax rates. The taxable items are standardized by means of positive enumeration and their tax rates are clarified by category, which provides an institutional basis for streamlining tax declaration. Thirdly, strengthening the interdepartmental cooperation. Tax authorities and natural resources and other relevant departments should establish a work coordination mechanism to reduce disputes and safeguard lawful rights and interests of taxpayers.
3. 土地管理法、城市房地产管理法修改决定表决通过
2019年8月26日，第十三届全国人大常委会第十二次会议通过并公布《全国人民代表大会常务委员会关于修改〈中华人民共和国土地管理法〉、〈中华人民共和国城市房地产管理法〉的决定》，自2020年1月1日起施行。
土地管理法带来以下三方面变化：一、破除农村集体经营性建设用地入市的法律障碍；二、首次对于哪些是公共利益可以动用国家征收权作出了明确的界定；三、完善了土地征收程序，政府征地前要与被征地农民协商。
《中华人民共和国城市房地产管理法》将第九条修改为：“城市规划区内的集体所有的土地，经依法征收转为国有土地后，该幅国有土地的使用权方可有偿出让，但法律另有规定的除外。”
3. Decision to Amend Land Administration Law and Urban Real Estate Administration Law Adopted
On August 26, 2019, the 12th Session of the Standing Committee of the Thirteenth National People's Congress passed the Decision of the Standing Committee of the National People's Congress to Amend the Land Administration Law and the Urban Real Estate Administration Law, effective from January 1, 2020.
The Land Administration law shows the following three changes: first, breaking the legal barriers to the marketization of rural collective land designated for business-related construction; second, clarifying specific circumstances under which the state may expropriate the land for the public interest for the first time; third, improving the land expropriation procedures, among which the government is required to consult with the farmers whose land is to be expropriated before expropriation.
Article 9 of the Urban Real Estate Administration Law is amended to read: “For a piece of collectively-owned land within the urban planning area, it must be requisitioned and turned into state-owned land according to the law first and then the land use right of it could be transferred with due compensation, unless it is otherwise prescribed by any law.”
4. 《科创板上市公司重大资产重组特别规定》发布
2019年8月23日，证监会发布《科创板上市公司重大资产重组特别规定》，自公布之日起施行。
该《特别规定》坚持市场化、法治化原则，突出科创板制度的包容性和适应性，对科创公司重大资产重组认定标准、发行定价机制、创新试点红筹企业并购重组等重点问题作出规定。规定明确，科创公司发行股份购买资产实施注册制，由上海证券交易所进行审核，证监会收到上海证券交易所报送的审核意见等相关文件后，在5个交易日内对科创公司注册申请作出同意或者不予注册的决定。注册制的实施，将有效提升科创公司并购重组效率。
4. Special Provisions on Material Asset Restructurings of Companies Listed on the SSE STAR Market Issued
On August 23, 2019, the China Securities Regulatory Commission (CSRC) issued the Special Provisions on the Material Asset Restructurings of Companies Listed on the SSE STAR Market, effective from the date of issuance.
Adhering to the principles of marketization and rule of law and highlighting the inclusiveness and adaptability of the system of the Shanghai Stock Exchange Sci-Tech Innovation Board (SSE STAR market), the Special Provisions stipulate the key issues concerning companies listed on the SSE STAR market such as the determination criteria of material asset restructurings, issuance pricing mechanism, and Merger and Acquisition (M&A) and restructurings of red chip enterprises under the innovation pilot program. In addition, as stated by the Special Provisions, the issuance of shares to purchase assets by companies listed on the STAR market should be subject to the registration system, under which the SSE is in charge of examination, and then the CSRC should, within five trading days upon receipt of relevant documents including examination opinions submitted by the SSE, make a decision on whether to approve or reject the registration applications filed by companies. The implementation of the registration system will effectively improve the efficiency of the M&A and restructurings of companies listed on the STAR market.
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