27

2013

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05

The EU lists a"schedule"for the new regulations on APIs

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Recently,the Pharmaceutical Commission of the European Commission(EC)stated that China and India still have more work to do in confirming that their API manufacturers meet the EU GMP requirements.

According to the newly promulgated new regulations on APIs in the EU,countries outside the EU must provide written confirmation of GMP compliance from July 2 this year,in order to provide conditions for domestic manufacturers to import APIs into the EU region.In order to make adequate preparations for this upcoming deadline,the EC Drug Commission has issued a progress report.The report states that each of the 20 major countries is ready to comply with the new rules.

"China and India are making good progress"

According to the EU's Counterfeit Drugs Directive(FMD),each country can choose to issue its own"written confirmation"through the appropriate competent authority,or can choose to apply for inclusion in a"third country"list to demonstrate that it has the same monitoring and inspection system as the EU.

The EC Drug Commission has pointed out that in other special circumstances,when it is necessary to ensure the supply of certain pharmaceutical products,a written confirmation of this need can be exempted by a member state of the European Union,provided that the country has conducted inspections on specific manufacturing plants.

The EC Drug Commission stated that China and India have made"good progress"in preparing to issue written confirmations,with India introducing implementation rules for GMP compliance,and China has announced that it will issue written confirmations.India has previously stated that it will establish a competent authority to ensure that API exporters can meet the new requirements of the EU.These two countries have a total of 934 API manufacturers,accounting for over 60%of the total number of API manufacturers listed by the European Commission.

However,the EC Drug Commission said that China's drug regulatory authority has stated that it will not issue written confirmation to manufacturers that do not accept its supervision.The EC Medicines Commission said that the European Medicines Agency(EMA)would coordinate inspections of these manufacturers.

Four other countries have agreed to provide their own written confirmation,but they are included in the category of"more work needs to be done-especially by industry stakeholders".The four countries are Argentina(12 API manufacturers),Malaysia(7),Thailand(6),and Russia(5).The European Commission did not provide any additional information on the necessary work,but it stated that it was in communication with the relevant agencies of all the aforementioned countries except Russia.

update rule

Meanwhile,the United States,Brazil,Singapore,Japan,Israel,and Australia have all applied for exemption from the new EU rules.The EC Drug Commission pointed out that the EC will conduct on-site inspections in Japan and the United States in mid April and mid May respectively to assess the equivalence of the two countries.The committee added that the equality assessment for Australia was about to end.

However,applications for equality submitted by Israel and Singapore have been rejected.The two countries will issue a written confirmation before re applying for exemption requirements.Brazil has not provided appropriate documentation,and as the equivalence assessment for the country has not yet begun,Brazil will have to issue a written confirmation at that time.

Currently,Switzerland is the only country in the world to obtain equal sex status.

As for what the new equality rule will cover,the European Commission has recently updated its Frequently Asked Questions(Q&A)regarding the new provisions.

In Q&A,the European Commission clarified that written confirmation does not apply to plasma.However,processed plasma derivatives with pharmacological,immune,or metabolic effects are considered active substances and therefore require written confirmation.

In addition,active substances in investigational pharmaceutical products or investigational drugs used for research and development are excluded from the new rules.

EU,Pharmaceuticals