China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services.
(Barnet Siu; 2010)[citation needed] Investment conditions in China have improved due to the vast consumer demand for pharmaceuticals, the lower labor costs and the changes resulting from economic reform.
Most domestic manufacturers in the pharmaceutical industry lack the autonomic intellectual property and financial resources to develop their own brand products.
In the past three years 2015–2017, there were 35 FDA warning letters to Chinese pharmaceutical companies citing serious Data Integrity issues, including data deletion or manipulation or fabrication of test results, see "An Analysis of 2017 FDA Warning Letters on Data Integrity" By Barbara Unger, Unger Consulting Inc. An Analysis Of 2017 FDA Warning Letters On Data Integrity See the long list of Chinese pharmaceutical companies which have been placed on Import Alert by the FDA due to serious noncompliance with Good Manufacturing Procedures Import Alert 66-40 See the European Medicines Agency EudaGMDP Noncompliance Reports based on Inspections of companies that revealed serious noncompliance with Good Manufacturing Procedures: Eudra GMP - Public Layout See FDA Warning Letters detailing serious noncompliance with Good Manufacturing Procedures: Warning Letters In 2013, China had about 3,500 drug companies, falling from more than 5,000 in 2004, according to government figures.
The pharmaceutical market in China is dominated by its non-branded generic industry that operates with basic technology and simple production methods.
Retail pharmacy outlets are expected to grow in number once the government finally introduces its system to classify drugs as OTC.
China's huge and gradually aging population and strong biopharmaceutical sector have almost guaranteed a large but varied pharmaceutical market profile.
Each of these provinces has grown steadily by an average of 20 per cent per annum from 1998 to 2003 (with the exception of Jiangsu in 1998 and 1999) and reflects an increasingly healthy developing trend in the Chinese pharmaceutical industry.
The pharmaceutical industry in China grows well only in areas with a strong macroeconomic background rather than in regions with rich natural resources or advanced science and technology.
The number of drug companies under each administrative department is often wrongly recorded resulting in an inaccurate evaluation index of the regional economic development and governmental performance.
Many Chinese companies not only produce the dosage forms (such as tablets) but also own the pharmacies where they are dispensed, as well as the distribution networks that deliver them to the hospitals, where nearly 80% of drugs are sold.
The R&D system consists of specialized research institutes, major universities, biotechnology companies, and R&D divisions of large pharmaceutical enterprises.
During the past several years, some Chinese pharmaceutical companies began to establish R&D infrastructures largely due to internal growth needs, but their primary focus is directed toward improving existing technologies or developing generic version of new drugs.
The biggest differences include following: When the Chinese are developing an API they try patent searches via the internet, but are limited by the scope of the available services.
Few factories yet have patent attorneys on staff, but for the larger pharma groups who are seeking partnerships with large Western firms, this may come soon.
In most cases, the agents buy the pharmacy products with cash after weighing the costs and profits, and the market risks lie with the wholesalers.
What needs to be pointed out is that in China, the biggest pharmacy retailer is the hospital, due to the country's medicare and social security mechanisms.
In recent years, more and more western pharmaceutical corporations, such as Pfizer, GSK, Roche, Novo Nordisk, have set up commercial operations and R&D centers in China.
As of 2004 (three years after China's WTO entry), nearly all global pharmaceutical companies have already completed their accession into the Chinese market and will gradually shift their focus to research development.
ICI, the predecessor of the world's No 3 pharmacy enterprise AstraZeneca, began trade with China in 1898, and still maintained its old-time office by the Huangpu River in Shanghai.
In June 2009, Nigeria seized a large consignment of fake anti-malarial drugs with the label of 'made in India' but found that the medicines were in fact produced in China and were imported into the African countries.
Nonetheless, the Ministry of Health retains its other main functions-regulatory development and oversight, healthcare resource allocation, and medical research and education.
SFDA did so to encourage patients to purchase OTC medicines for less serious diseases, thereby reducing government medication expenditures and hospital visits.
Following WTO regulations, China has committed itself to cutting tariffs, liberalizing its domestic distribution practices, and restructuring its regulatory environment.
Furthermore, China has also implemented new drug administration laws designed to streamline product registration and protect Intellectual Property Rights (IPR).
As a result, some unfair, unjustified and unreasonable practices surface as decision makers of some hospitals abused their power in order to get economic benefits.
The enforcement of Good Manufacturing Practices has not been adequate in China and the U.S. FDA and EMA (European Medicines Agency) have inspected Chinese pharmaceutical plants that export to their countries and found many to be seriously non compliant with GMP.
Corporations such as Alliance Boots have formed retail and distribution joint ventures in China, mainly focused on Guangdong province.
Experts estimate that the industry will reach $10 billion in annual sales by 2010, and will continue as consumers seek products with curative weight loss and other health enhancing effects.
Companies say that complicated product registration, expensive and time-consuming certification requirements, and inexperienced and inefficient distributors are common obstacles.