China’s National Medical Products Administration issued guidelines for the imports of reference products of biomedicines for clinical trials, according to a July 5 report from the Hong Kong Trade Development Council. Among the key points in the guidelines, China is urging applicants to import “original drugs already approved by China for general import” when they conduct “equivalence tests on their proposed biosimilar products.” In addition, if the location where the imported drug was produced differs “from that of the drug previously approved for import,” the applicant is required to “demonstrate the consistency of the drug across its various production bases or conduct research to establish such consistency,” the report said. In either case, the applicant must submit a “supplemental application” to the NMPA’s Center for Drug Evaluation. Drugs that are sourced from an “unapproved location” will not be allowed as part of a clinical trial until the center “has duly accredited it,” the report said.

South Korea criticized Japan’s recent decision to increase restrictions on certain technology exports to South Korea, calling the move “a form of political retaliation” and threatening retaliatory action, according to a July 5 report from The Korea Herald posted on the Asia News Network website. Japan’s Ministry of Economy, Trade and Industry announced plans to increase export restrictions on high-tech items used for smartphones and chips, effective July 4. The move will impact large South Korean technology companies such as Samsung and LG Display (see 1907010020). South Korea’s National Security Council called the move a violation of international law and “vowed active diplomatic countermeasures” against Japan, the news report said. South Korea’s Deputy Prime Minister and Finance Minister Hong Nam-ki also said the country plans to take “corresponding measures,” including filing a complaint with the World Trade Organization, according to the report.

Singapore and New Zealand recently signed agreements to recognize each other’s authorized economic operator programs, Singapore Customs said in a press release. “Companies certified by Singapore Customs as having robust security practices will benefit from faster clearance for their goods exported to New Zealand,” the release said. “Companies certified by New Zealand will similarly receive the same level of facilitation for their goods exported to Singapore,” it said.

Hong Kong recently signed mutual recognition arrangements on authorized economic operator programs with Canada (see 1907010035) and Israel, the Hong Kong Customs and Excise Department (C&ED) said in a June 29 press release. Under the agreements, Hong Kong will recognize members of Canadian and Israeli AEO programs for customs clearance facilitation purposes, and Hong Kong AEOs will receive reciprocal treatment in Canada and Israel, the release said. “The inspection rate for AEO cargoes is generally 80 per cent lower compared with that for non-AEO cargoes,” C&ED said. The two MRAs mean Hong Kong now has a total of 11 with countries around the world, including China, India, Korea, Singapore, Thailand, Malaysia, Japan, Australia and New Zealand.

Exporters that produce and send goods from Puerto Rico to China may be able to avoid some of the tariffs on U.S. goods by using the U.S. territory as the origin, said Susie Hoeger, director of Global Trade Compliance and Policy at Abbott Laboratories. Hoeger mentioned the tip while speaking at the American Association of Exporters and Importers Annual Conference in Washington on June 27. "Chinese Customs has chosen to treat Puerto Rico differently than the U.S.," she said. "So if you don't know this and make things in Puerto Rico, declaring that as Puerto Rico origin instead of U.S., which is all the same for us, the tariffs don't hit. They've chosen to carve that out for some reason." Census Bureau statistics seem to show a recent uptick in exports to China from Puerto Rico. According to Census, the value of goods exported from the territory to China increased by 53.6 percent from 2017 to 2018.

Singapore importers of cigarettes will soon be required to file the Singapore Duty-Paid Cigarette marking applications online instead of providing physical copies, Singapore Customs said in a July 1 notice. All importers and manufacturers of cigarettes must obtain Customs approval on “new brands or variants of cigarettes” and are required to fill out the “Singapore Duty-Paid Cigarette” form online, available starting July 1, the notice said. Singapore Customs plans to phase out the physical copies and only accept online applications by Aug. 30.

China recently adopted new requirements on importation of medicines that will take effect at the beginning of 2020, according to an alert from the Hong Kong Trade Development Council. Key changes include the removal of some restrictions on ports that may be used to import medicinal materials. China will also allow importation of medicines that comply with standards set by its provinces and autonomous regions if no national standards apply, HKTDC said. China is also simplifying clearance procedures for medicinal materials that are not being imported for the first time, according to an unofficial translation of a press release from the Chinese State Administration for Market Regulation.

Japan’s Ministry of Economy, Trade and Industry is implementing more restrictions surrounding licensing policies and procedures for exports of certain “controlled items” and technologies to South Korea, the ministry said in a July 1 press release. Japan said its relationship of trust with South Korea “in the field of export control and regulation” has been “significantly undermined.” Japan said it will “apply more stringent procedures over certain controlled items and their relevant technologies” to “ensure appropriate implementation of Japan’s own export control and regulation.” Some “sensitive items” have been exported to South Korea “with inadequate management by companies,” the press release said. The changes will take effect July 4, Japan said.

Laos recently set new certificate requirements for non-resident importers and exporters that were set to take effect June 27, according to an alert from the law firm Tilleke & Gibbons. Under the new regulation, importers and exporters in Laos that have no registered business in the country will require a Trading Rights Certificate from the Department of Import and Export in order to sell and purchase goods. The goods can’t be sold directly to consumers in Laos, and must be sold through authorized distributors. To be eligible for a certificate, the importer or exporter must operate in accordance with the laws of their country of origin, have not committed an offense or be involved in criminal proceedings related to trade or financial matters, and must come from a World Trade Organization member country.

Thailand announced a 90-day ban on pig imports from Laos after Laos confirmed it is dealing with an outbreak of African swine fever, according to a June 22 report by Reuters, which cited an official Thailand government agency notice from June 21. The ban covers live pigs and pig carcasses, and follows a recent decision by China to also ban pigs from Laos, Reuters reported.